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Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02953782
Recruitment Status : Completed
First Posted : November 3, 2016
Results First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Solid Tumor
Colorectal Cancer
Interventions Drug: Magrolimab
Drug: Cetuximab
Enrollment 78
Recruitment Details Participants were enrolled at study sites in United States. The first participant was screened on 02 November 2016. The last study visit occurred on 10 February 2020.
Pre-assignment Details 105 participants were screened.
Arm/Group Title Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Hide Arm/Group Description Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by intravenous (IV) infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented progressive disease (PD). Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with advanced colorectal cancer (CRC) who were KRAS wild type (KRASwt) and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with advanced CRC with KRAS mutation (KRASm) who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Period Title: Phase 1b (Maximum Duration: 14.3 Months)
Started 6 3 9 8 6 0 0 0
Completed 0 0 0 0 0 0 0 0
Not Completed 6 3 9 8 6 0 0 0
Reason Not Completed
Death             5             2             6             6             4             0             0             0
Withdrawal by Subject             1             0             2             0             1             0             0             0
Discontinued by Sponsor             0             1             0             1             1             0             0             0
Participant placed in hospice care             0             0             1             1             0             0             0             0
Period Title: Phase 2 (Maximum Duration: 11.1 Months)
Started 0 0 0 0 0 16 [1] 15 15
Completed 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 16 15 15
Reason Not Completed
Death             0             0             0             0             0             14             11             8
Withdrawal by Subject             0             0             0             0             0             1             2             3
Discontinued by Sponsor             0             0             0             0             0             1             1             4
Lost to Follow-up             0             0             0             0             0             0             1             0
[1]
11 participants were included in safety run-in to evaluate DLT. 9 out of 11 were evaluable for DLT.
Arm/Group Title Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Total
Hide Arm/Group Description Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD. Total of all reporting groups
Overall Number of Baseline Participants 6 3 9 8 6 16 15 15 78
Hide Baseline Analysis Population Description
All Treated participants included all participants who received at least 1 dose of any study drugs.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 9 participants 8 participants 6 participants 16 participants 15 participants 15 participants 78 participants
62.6  (6.72) 68.6  (11.39) 57.3  (7.05) 52.4  (10.97) 63.6  (9.50) 59.7  (14.38) 58.9  (14.41) 57.4  (5.80) 58.9  (11.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants 8 participants 6 participants 16 participants 15 participants 15 participants 78 participants
Female 2 0 2 2 2 6 8 5 27
Male 4 3 7 6 4 10 7 10 51
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants 8 participants 6 participants 16 participants 15 participants 15 participants 78 participants
Hispanic or Latino 1 0 1 0 1 4 1 0 8
Not Hispanic or Latino 5 3 8 8 5 12 13 11 65
Unknown or Not Reported 0 0 0 0 0 0 1 4 5
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants 8 participants 6 participants 16 participants 15 participants 15 participants 78 participants
American Indian or Alaska Native 0 0 0 0 0 1 0 0 1
Asian 0 0 0 0 0 1 1 3 5
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0 0 0
Black or African American 1 0 1 0 0 2 1 0 5
White 5 3 7 8 6 8 10 8 55
More than one race 0 0 0 0 0 0 0 0 0
Unknown or Not Reported 0 0 1 0 0 4 3 4 12
1.Primary Outcome
Title Percentage of Participants With Dose Limiting Toxicities (DLT)
Hide Description

DLT was defined as any Grade (GR) 3 or greater adverse event (AE) that was assessed as related to study treatment with the exceptions of:

GR 3: anemia (hemolytic anemia that is medically significant tis considered a DLT), indirect/unconjugated hyperbilirubinemia, electrolyte abnormalities, elevation in alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase that resolved to ≤ Grade 2 with supportive care within 1 week and is not associated with other clinically significant consequences; nausea, vomiting, or diarrhea that resolved to ≤ Grade 2 with supportive care within 72 hours; fatigue that resolved to ≤ Grade 2 within 2 weeks on study; drug-related infusion reactions in the absence of an optimal pretreatment regimen; tumor lysis syndrome or electrolyte disturbances, hypomagnesemia, that resolved to ≤ Grade 2 or baseline within 1 week;

GR 3 or 4: lymphopenia or leukopenia.
Time Frame From first dose up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
DLT Evaluable Analysis Set included participants who received at least 1 dose of any study drugs during Phase 1b if the participant either experienced a DLT any time during the DLT assessment period (the first 4 weeks of treatment) or completed at least 4 infusions of magrolimab and 2 infusions of cetuximab.
Arm/Group Title Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Hide Arm/Group Description:
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m^2 infusions given over 60 minutes.
Overall Number of Participants Analyzed 6 3 9 7 6 9
Measure Type: Number
Unit of Measure: percentage of participants
16.7 0.0 0.0 14.3 0.0 0.0
2.Primary Outcome
Title Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Hide Description An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as AEs worsening or occurring during or after a participant's first exposure to study drug and within 30 days after the last administration of study drug or initiation of new anticancer therapy, whichever occurred first.
Time Frame From first dose date up to last dose date plus 30 days (maximum: 15.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated included all participants who received at least 1 dose of any study drugs.
Arm/Group Title Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Magrolimab Priming Dose Only
Hide Arm/Group Description:
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
Overall Number of Participants Analyzed 6 3 10 7 6 14 15 14 3
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
3.Primary Outcome
Title Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Hide Description Objective response rate was defined as the percentage of participants with objective response which consisted of complete response (CR)+ partial response (PR) determined by RECIST v 1.1. CR: Disappearance of all target and all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis). Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame From Screening until 38.89 months (assessed on Day 1 of Cycle 3 then every 8 weeks [Q8W] from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
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Hide Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
Arm/Group Title KRASwt CRC KRASm CRC
Hide Arm/Group Description:
All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Overall Number of Participants Analyzed 32 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.3
(0.8 to 20.8)
0.0
(0.0 to 8.4)
4.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Cmax of Magrolimab
Hide Description Cmax is defined as the maximum concentration of drug.
Time Frame Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 1 (Cycle 1 Day 1), 8 (Cycle 1 Day 8), and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)
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Hide Analysis Population Description
Participants in the PK Analysis Set (participants who received any amount of magrolimab with at least one detectable post-treatment serum concentration of magrolimab) with available data were analyzed.
Arm/Group Title Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Hide Arm/Group Description:
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRAS mutation who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Overall Number of Participants Analyzed 6 3 10 7 6 15 14 11
Mean (Standard Deviation)
Unit of Measure: μg/mL
Day 1 (Cycle 1 Day 1) Number Analyzed 6 participants 2 participants 10 participants 7 participants 6 participants 15 participants 11 participants 11 participants
1.04  (0.769) 0.629  (0.437) 0.662  (0.374) 0.432  (0.173) 0.517  (0.311) 0.479  (0.170) 0.559  (0.254) 0.525  (0.296)
Day 8 (Cycle 1 Day 8) Number Analyzed 6 participants 3 participants 9 participants 7 participants 6 participants 9 participants 14 participants 11 participants
209  (82.0) 230  (54.6) 455  (105) 558  (168) 1100  (287) 513  (148) 616  (121) 901  (131)
Day 29 (Cycle 2 Day 1) Number Analyzed 5 participants 3 participants 8 participants 5 participants 6 participants 0 participants 2 participants 2 participants
312  (121) 352  (68.4) 728  (207) 982  (182) 2140  (590) 775  (110) 1790  (49.5)
5.Secondary Outcome
Title PK Parameter: Tmax of Magrolimab
Hide Description Tmax is defined as the time (observed time point) of Cmax.
Time Frame Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.
Arm/Group Title Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Hide Arm/Group Description:
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Overall Number of Participants Analyzed 6 3 9 7 6 9 14 11
Median (Full Range)
Unit of Measure: days
Day 8 (Cycle 1 Day 8) Number Analyzed 6 participants 3 participants 9 participants 7 participants 6 participants 9 participants 14 participants 11 participants
0.10
(0.09 to 0.12)
0.12
(0.09 to 0.13)
0.12
(0.12 to 6.94)
0.14
(0.12 to 0.85)
0.13
(0.12 to 3.90)
0.12
(0.08 to 6.82)
0.13
(0.12 to 0.17)
0.12
(0.11 to 6.99)
Day 29 (Cycle 2 Day 1) Number Analyzed 5 participants 3 participants 8 participants 5 participants 6 participants 0 participants 2 participants 2 participants
0.94
(0.10 to 1.09)
0.13
(0.12 to 0.13)
0.13
(0.12 to 0.96)
0.13
(0.10 to 0.15)
0.12
(0.12 to 0.13)
0.14
(0.14 to 0.14)
0.12
(0.12 to 0.12)
6.Secondary Outcome
Title PK Parameter: AUClast of Magrolimab
Hide Description AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time Frame Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.
Arm/Group Title Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Hide Arm/Group Description:
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Overall Number of Participants Analyzed 5 3 9 6 6 1 0 0
Mean (Standard Deviation)
Unit of Measure: day*μg/mL
Day 8 (Cycle 1 Day 8) Number Analyzed 0 participants 2 participants 9 participants 6 participants 6 participants 1 participants 0 participants 0 participants
676  (75.3) 1530  (513) 2140  (726) 2920  (600) 1930
Day 29 (Cycle 2 Day 1) Number Analyzed 5 participants 3 participants 8 participants 3 participants 6 participants 0 participants 0 participants 0 participants
1420  (711) 1560  (413) 3330  (1270) 4480  (1220) 7340  (2380)
7.Secondary Outcome
Title PK Parameter: AUCtau of Magrolimab
Hide Description AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time Frame Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.
Arm/Group Title Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Hide Arm/Group Description:
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Overall Number of Participants Analyzed 4 3 7 6 4 1 0 0
Mean (Standard Deviation)
Unit of Measure: day*μg/mL
Day 8 (Cycle 1 Day 8) Number Analyzed 0 participants 2 participants 5 participants 6 participants 0 participants 1 participants 0 participants 0 participants
676  (75.3) 1630  (649) 2140  (726) 1930
Day 29 (Cycle 2 Day 1) Number Analyzed 4 participants 3 participants 7 participants 3 participants 4 participants 0 participants 0 participants 0 participants
1640  (604) 1560  (413) 3630  (1040) 4480  (1220) 8770  (1120)
8.Secondary Outcome
Title Percentage of Participants With Anti-drug Antibodies (ADA)
Hide Description Percentage of Participants With Positive ADA at any timepoint was reported.
Time Frame Baseline; post-treatment (assessed continuously up to 30 days after last dose; maximum 15.3 months )
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity Analysis Set included participants with at least one reported ADA result.
Arm/Group Title Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Hide Arm/Group Description:
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Overall Number of Participants Analyzed 6 3 10 7 6 16 15 15
Measure Type: Number
Unit of Measure: percentage of participants
Baseline ADA Number Analyzed 6 participants 3 participants 10 participants 7 participants 6 participants 16 participants 15 participants 15 participants
0.00 0.00 0.00 14.3 0.00 6.3 0.00 0.00
Post-Treatment ADA Number Analyzed 6 participants 3 participants 10 participants 7 participants 6 participants 16 participants 15 participants 14 participants
33.3 0.00 0.00 0.00 0.00 6.3 13.3 0.00
Overall ADA Number Analyzed 6 participants 3 participants 10 participants 7 participants 6 participants 16 participants 15 participants 15 participants
33.3 0.00 0.00 14.3 0.00 12.5 13.3 0.00
9.Secondary Outcome
Title Disease Control Rate (DCR) as Assessed by RECIST v1.1
Hide Description DCR was defined as the percentage of participants with disease control which consisted of CR+PR+SD. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters measured while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions.
Time Frame From Screening until 38.89 months (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
Arm/Group Title KRASwt CRC KRASm CRC
Hide Arm/Group Description:
All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Overall Number of Participants Analyzed 32 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(31.9 to 68.1)
38.1
(23.6 to 54.4)
10.Secondary Outcome
Title Duration of Response (DOR) as Assessed by RECIST v1.1
Hide Description DOR was measured from when the first (objective) response was met (i.e., CR or PR) until the first date of objectively documented PD. Participants who did not have objectively PD was censored at their last documented progression-free date. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Kaplan Meier estimate was used for analysis.
Time Frame From first objective response until documented PD (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
Arm/Group Title KRASwt CRC KRASm CRC
Hide Arm/Group Description:
All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Overall Number of Participants Analyzed 2 0
Median (95% Confidence Interval)
Unit of Measure: months
9.7
(7.0 to 12.5)
11.Secondary Outcome
Title Progression Free Survival (PFS) as Assessed by RECIST v1.1
Hide Description PFS was measured from first dose until the first date of objectively documented PD or death. Participants who did not have objectively documented PD and not died was censored at their last documented progression-free date. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Kaplan Meier estimate was used for analysis.
Time Frame From first dose until documented PD/death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
Arm/Group Title KRASwt CRC KRASm CRC
Hide Arm/Group Description:
All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Overall Number of Participants Analyzed 32 42
Median (95% Confidence Interval)
Unit of Measure: months
3.6
(1.8 to 5.4)
1.9
(1.8 to 3.5)
12.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was measured from first dose until death. Participants who did not die were censored at their last known alive date. Kaplan Meier estimate was used for analysis.
Time Frame From first dose until death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.
Arm/Group Title KRASwt CRC KRASm CRC
Hide Arm/Group Description:
All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Overall Number of Participants Analyzed 32 42
Median (95% Confidence Interval)
Unit of Measure: months
9.5
(5.9 to 12.6)
7.6
(5.4 to 11.7)
Time Frame Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
Adverse Event Reporting Description All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.
 
Arm/Group Title Magrolimab 10 mg/kg Magrolimab 20 mg/kg Magrolimab 30 mg/kg Magrolimab 45 mg/kg Magrolimab Priming Dose Only
Hide Arm/Group Description Participants who received magrolimab maintenance dose of 10 mg/kg in combination with cetuximab in any part of the study. Participants who received magrolimab maintenance dose of 20 mg/kg in combination with cetuximab in any part of the study. Participants who received magrolimab maintenance dose of 30 mg/kg in combination with cetuximab in any part of the study. Participants who received magrolimab maintenance dose of 45 mg/kg in combination with cetuximab in any part of the study. Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
All-Cause Mortality
Magrolimab 10 mg/kg Magrolimab 20 mg/kg Magrolimab 30 mg/kg Magrolimab 45 mg/kg Magrolimab Priming Dose Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/9 (77.78%)   8/10 (80.00%)   30/36 (83.33%)   14/20 (70.00%)   3/3 (100.00%) 
Hide Serious Adverse Events
Magrolimab 10 mg/kg Magrolimab 20 mg/kg Magrolimab 30 mg/kg Magrolimab 45 mg/kg Magrolimab Priming Dose Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/9 (33.33%)   6/10 (60.00%)   10/36 (27.78%)   5/20 (25.00%)   1/3 (33.33%) 
Blood and lymphatic system disorders           
Anaemia † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Immune thrombocytopenic purpura † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Cardiac disorders           
Bradycardia † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders           
Constipation † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  1/3 (33.33%) 
Enterocolitis † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Faecaloma † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Large intestinal obstruction † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Small intestinal obstruction † 1  2/9 (22.22%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
General disorders           
Complication associated with device † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Pyrexia † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Infections and infestations           
Bacterial sepsis † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Cystitis † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Post procedural infection † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Urinary tract infection † 1  0/9 (0.00%)  2/10 (20.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications           
Infusion related reaction † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Investigations           
Bilirubin conjugated increased † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
International normalised ratio increased † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders           
Dehydration † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Hyperkalaemia † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Hypokalaemia † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders           
Pathological fracture † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Malignant neoplasm progression † 1  1/9 (11.11%)  1/10 (10.00%)  3/36 (8.33%)  1/20 (5.00%)  1/3 (33.33%) 
Tumour pain † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Nervous system disorders           
Cerebrovascular accident † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders           
Acute kidney injury † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Respiratory failure † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Vascular disorders           
Haemorrhage † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Magrolimab 10 mg/kg Magrolimab 20 mg/kg Magrolimab 30 mg/kg Magrolimab 45 mg/kg Magrolimab Priming Dose Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   10/10 (100.00%)   36/36 (100.00%)   20/20 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders           
Anaemia † 1  1/9 (11.11%)  1/10 (10.00%)  11/36 (30.56%)  4/20 (20.00%)  0/3 (0.00%) 
Immune thrombocytopenic purpura † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Iron deficiency anaemia † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Lymph node pain † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Lymphopenia † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Cardiac disorders           
Palpitations † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Tachycardia † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Ear and labyrinth disorders           
Deafness † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  1/3 (33.33%) 
Tinnitus † 1  2/9 (22.22%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Eye disorders           
Blepharal pigmentation † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Conjunctivitis allergic † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Dry eye † 1  1/9 (11.11%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Photopsia † 1  1/9 (11.11%)  2/10 (20.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Strabismus † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Vision blurred † 1  0/9 (0.00%)  0/10 (0.00%)  3/36 (8.33%)  0/20 (0.00%)  0/3 (0.00%) 
Vitreous floaters † 1  0/9 (0.00%)  0/10 (0.00%)  3/36 (8.33%)  0/20 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders           
Abdominal distension † 1  1/9 (11.11%)  3/10 (30.00%)  4/36 (11.11%)  1/20 (5.00%)  0/3 (0.00%) 
Abdominal pain † 1  3/9 (33.33%)  3/10 (30.00%)  6/36 (16.67%)  2/20 (10.00%)  2/3 (66.67%) 
Abdominal pain lower † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Abdominal pain upper † 1  0/9 (0.00%)  1/10 (10.00%)  3/36 (8.33%)  0/20 (0.00%)  0/3 (0.00%) 
Ascites † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Constipation † 1  1/9 (11.11%)  5/10 (50.00%)  6/36 (16.67%)  6/20 (30.00%)  0/3 (0.00%) 
Diarrhoea † 1  4/9 (44.44%)  3/10 (30.00%)  9/36 (25.00%)  7/20 (35.00%)  1/3 (33.33%) 
Dry mouth † 1  0/9 (0.00%)  1/10 (10.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Dyspepsia † 1  1/9 (11.11%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Dysphagia † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Enterocolitis † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Gastrooesophageal reflux disease † 1  1/9 (11.11%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  1/3 (33.33%) 
Glossodynia † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Hypoaesthesia oral † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Intestinal obstruction † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Loose tooth † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Nausea † 1  2/9 (22.22%)  2/10 (20.00%)  16/36 (44.44%)  3/20 (15.00%)  1/3 (33.33%) 
Oesophageal pain † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Rectal discharge † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Stomatitis † 1  0/9 (0.00%)  2/10 (20.00%)  8/36 (22.22%)  6/20 (30.00%)  0/3 (0.00%) 
Vomiting † 1  1/9 (11.11%)  3/10 (30.00%)  11/36 (30.56%)  4/20 (20.00%)  1/3 (33.33%) 
General disorders           
Chest discomfort † 1  1/9 (11.11%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Chest pain † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Chills † 1  2/9 (22.22%)  2/10 (20.00%)  11/36 (30.56%)  5/20 (25.00%)  0/3 (0.00%) 
Early satiety † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Fatigue † 1  4/9 (44.44%)  5/10 (50.00%)  18/36 (50.00%)  7/20 (35.00%)  0/3 (0.00%) 
Gait disturbance † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  1/3 (33.33%) 
Influenza like illness † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Non-cardiac chest pain † 1  0/9 (0.00%)  1/10 (10.00%)  3/36 (8.33%)  1/20 (5.00%)  0/3 (0.00%) 
Oedema † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Oedema peripheral † 1  2/9 (22.22%)  0/10 (0.00%)  2/36 (5.56%)  2/20 (10.00%)  0/3 (0.00%) 
Pain † 1  0/9 (0.00%)  0/10 (0.00%)  3/36 (8.33%)  0/20 (0.00%)  1/3 (33.33%) 
Performance status decreased † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  1/3 (33.33%) 
Pyrexia † 1  0/9 (0.00%)  2/10 (20.00%)  13/36 (36.11%)  8/20 (40.00%)  1/3 (33.33%) 
Hepatobiliary disorders           
Hyperbilirubinaemia † 1  0/9 (0.00%)  1/10 (10.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Infections and infestations           
Bronchitis † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Conjunctivitis † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Cystitis † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Folliculitis † 1  1/9 (11.11%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Gastroenteritis viral † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Herpes zoster † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Lung infection † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Nail infection † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Paronychia † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Pharyngitis † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Sinusitis † 1  1/9 (11.11%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Skin infection † 1  1/9 (11.11%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Tinea cruris † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Tooth abscess † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Upper respiratory tract infection † 1  0/9 (0.00%)  2/10 (20.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Vaginal infection † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Viral upper respiratory tract infection † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications           
Fall † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Gastrointestinal stoma complication † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Infusion related reaction † 1  3/9 (33.33%)  3/10 (30.00%)  12/36 (33.33%)  7/20 (35.00%)  1/3 (33.33%) 
Pelvic fracture † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Investigations           
Alanine aminotransferase increased † 1  1/9 (11.11%)  2/10 (20.00%)  4/36 (11.11%)  1/20 (5.00%)  0/3 (0.00%) 
Aspartate aminotransferase increased † 1  1/9 (11.11%)  2/10 (20.00%)  5/36 (13.89%)  1/20 (5.00%)  1/3 (33.33%) 
Blood alkaline phosphatase increased † 1  0/9 (0.00%)  2/10 (20.00%)  2/36 (5.56%)  1/20 (5.00%)  1/3 (33.33%) 
Blood bilirubin increased † 1  1/9 (11.11%)  3/10 (30.00%)  5/36 (13.89%)  5/20 (25.00%)  1/3 (33.33%) 
Blood lactate dehydrogenase increased † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  1/3 (33.33%) 
Blood sodium decreased † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Electrocardiogram QT prolonged † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Lymphocyte count decreased † 1  4/9 (44.44%)  1/10 (10.00%)  3/36 (8.33%)  3/20 (15.00%)  0/3 (0.00%) 
Platelet count decreased † 1  1/9 (11.11%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Weight decreased † 1  0/9 (0.00%)  2/10 (20.00%)  3/36 (8.33%)  1/20 (5.00%)  0/3 (0.00%) 
White blood cell count decreased † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite † 1  2/9 (22.22%)  3/10 (30.00%)  9/36 (25.00%)  5/20 (25.00%)  0/3 (0.00%) 
Dehydration † 1  2/9 (22.22%)  2/10 (20.00%)  4/36 (11.11%)  3/20 (15.00%)  0/3 (0.00%) 
Hyperglycaemia † 1  1/9 (11.11%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Hypokalaemia † 1  1/9 (11.11%)  2/10 (20.00%)  5/36 (13.89%)  4/20 (20.00%)  0/3 (0.00%) 
Hypomagnesaemia † 1  1/9 (11.11%)  4/10 (40.00%)  10/36 (27.78%)  5/20 (25.00%)  0/3 (0.00%) 
Hyponatraemia † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Hypophosphataemia † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Iron deficiency † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Lactic acidosis † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  1/3 (33.33%) 
Malnutrition † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  2/20 (10.00%)  0/3 (0.00%) 
Back pain † 1  2/9 (22.22%)  2/10 (20.00%)  5/36 (13.89%)  1/20 (5.00%)  0/3 (0.00%) 
Flank pain † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Muscle spasms † 1  0/9 (0.00%)  0/10 (0.00%)  4/36 (11.11%)  0/20 (0.00%)  0/3 (0.00%) 
Muscular weakness † 1  0/9 (0.00%)  0/10 (0.00%)  3/36 (8.33%)  0/20 (0.00%)  0/3 (0.00%) 
Musculoskeletal chest pain † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Musculoskeletal pain † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Myalgia † 1  2/9 (22.22%)  0/10 (0.00%)  3/36 (8.33%)  1/20 (5.00%)  0/3 (0.00%) 
Neck pain † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Tumour pain † 1  1/9 (11.11%)  2/10 (20.00%)  0/36 (0.00%)  2/20 (10.00%)  0/3 (0.00%) 
Nervous system disorders           
Cerebral infarction † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Dizziness † 1  1/9 (11.11%)  1/10 (10.00%)  3/36 (8.33%)  2/20 (10.00%)  0/3 (0.00%) 
Dysaesthesia † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Dysgeusia † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  1/20 (5.00%)  0/3 (0.00%) 
Headache † 1  2/9 (22.22%)  2/10 (20.00%)  17/36 (47.22%)  8/20 (40.00%)  1/3 (33.33%) 
Presyncope † 1  0/9 (0.00%)  1/10 (10.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Restless legs syndrome † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Somnolence † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Syncope † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Tremor † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Psychiatric disorders           
Anxiety † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Confusional state † 1  1/9 (11.11%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Depression † 1  1/9 (11.11%)  1/10 (10.00%)  0/36 (0.00%)  4/20 (20.00%)  0/3 (0.00%) 
Insomnia † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  3/20 (15.00%)  0/3 (0.00%) 
Mental disorder † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  1/3 (33.33%) 
Restlessness † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Renal and urinary disorders           
Dysuria † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Haematuria † 1  1/9 (11.11%)  0/10 (0.00%)  2/36 (5.56%)  2/20 (10.00%)  0/3 (0.00%) 
Hydronephrosis † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Pollakiuria † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  1/3 (33.33%) 
Urinary hesitation † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Urinary retention † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough † 1  0/9 (0.00%)  0/10 (0.00%)  5/36 (13.89%)  4/20 (20.00%)  0/3 (0.00%) 
Dysphonia † 1  1/9 (11.11%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Dyspnoea † 1  1/9 (11.11%)  1/10 (10.00%)  11/36 (30.56%)  3/20 (15.00%)  0/3 (0.00%) 
Dyspnoea exertional † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Epistaxis † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  1/20 (5.00%)  0/3 (0.00%) 
Haemoptysis † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Hypoxia † 1  0/9 (0.00%)  1/10 (10.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Interstitial lung disease † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Laryngeal haemorrhage † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Nasal congestion † 1  1/9 (11.11%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Pulmonary congestion † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Pulmonary haemorrhage † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Rhinitis allergic † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  2/20 (10.00%)  0/3 (0.00%) 
Wheezing † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders           
Acne † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Dermatitis acneiform † 1  4/9 (44.44%)  5/10 (50.00%)  14/36 (38.89%)  6/20 (30.00%)  0/3 (0.00%) 
Dry skin † 1  6/9 (66.67%)  3/10 (30.00%)  8/36 (22.22%)  10/20 (50.00%)  0/3 (0.00%) 
Hyperhidrosis † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  1/3 (33.33%) 
Ingrowing nail † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  0/20 (0.00%)  0/3 (0.00%) 
Night sweats † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  0/20 (0.00%)  0/3 (0.00%) 
Pruritus † 1  2/9 (22.22%)  1/10 (10.00%)  7/36 (19.44%)  2/20 (10.00%)  0/3 (0.00%) 
Rash † 1  0/9 (0.00%)  1/10 (10.00%)  7/36 (19.44%)  2/20 (10.00%)  0/3 (0.00%) 
Rash maculo-papular † 1  2/9 (22.22%)  3/10 (30.00%)  7/36 (19.44%)  5/20 (25.00%)  1/3 (33.33%) 
Rash papular † 1  0/9 (0.00%)  0/10 (0.00%)  3/36 (8.33%)  0/20 (0.00%)  0/3 (0.00%) 
Rash pruritic † 1  0/9 (0.00%)  0/10 (0.00%)  4/36 (11.11%)  0/20 (0.00%)  0/3 (0.00%) 
Urticaria † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Vascular disorders           
Deep vein thrombosis † 1  1/9 (11.11%)  0/10 (0.00%)  1/36 (2.78%)  0/20 (0.00%)  0/3 (0.00%) 
Flushing † 1  0/9 (0.00%)  0/10 (0.00%)  1/36 (2.78%)  1/20 (5.00%)  0/3 (0.00%) 
Hypertension † 1  1/9 (11.11%)  0/10 (0.00%)  0/36 (0.00%)  2/20 (10.00%)  0/3 (0.00%) 
Hypotension † 1  0/9 (0.00%)  0/10 (0.00%)  2/36 (5.56%)  1/20 (5.00%)  1/3 (33.33%) 
Jugular vein thrombosis † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
Raynaud's phenomenon † 1  0/9 (0.00%)  0/10 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02953782    
Other Study ID Numbers: 5F9004
First Submitted: November 1, 2016
First Posted: November 3, 2016
Results First Submitted: February 8, 2021
Results First Posted: March 1, 2021
Last Update Posted: March 1, 2021