Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Magrolimab in Participants With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04827576
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

The primary objectives of the study are to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab + docetaxel combination therapy in solid tumors (Safety Run-in Cohort 1, Phase 2 Cohorts 1a,

1b, and 1c) and to evaluate the efficacy of magrolimab + docetaxel combination therapy in solid tumors as determined by investigator-assessed objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)


Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Magrolimab Drug: Docetaxel Phase 2

Detailed Description:

This study will consist of a Safety Run-in Cohort 1 (magrolimab + docetaxel combination). After completion of the Safety Run-in Cohort 1, Phase 2 Cohort 1 will occur as follows:

  • Phase 2 Cohort 1: a cohort of participants with solid tumors (metastatic non-small cell lung cancer (mNSCLC) (Phase 2 Cohort 1a), metastatic urothelial cancer (mUC) (Phase 2 Cohort 1b), and metastatic small cell lung cancer (mSCLC) (Phase 2 Cohort 1c).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Arm Study of Magrolimab in Patients With Solid Tumors
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Safety Run-in Cohort 1, mNSCLC, mUC, mSCLC (Magrolimab + Docetaxel)
Participants with solid tumors (metastatic non-small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), metastatic small cell lung cancer (mSCLC)) will receive an escalating dose of magrolimab and docetaxel.
Drug: Magrolimab
Administered intravenously
Other Name: GS-4721

Drug: Docetaxel
Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
Other Name: Taxotere®

Experimental: Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
Participants with mNSCLC will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety Run-in Cohort 1 and docetaxel.
Drug: Magrolimab
Administered intravenously
Other Name: GS-4721

Drug: Docetaxel
Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
Other Name: Taxotere®

Experimental: Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)
Participants with mUC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.
Drug: Magrolimab
Administered intravenously
Other Name: GS-4721

Drug: Docetaxel
Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
Other Name: Taxotere®

Experimental: Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
Participants with mSCLC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.
Drug: Magrolimab
Administered intravenously
Other Name: GS-4721

Drug: Docetaxel
Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
Other Name: Taxotere®




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Adverse Events According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [ Time Frame: First dose date up to 3 years ]
  2. Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE Version 5.0 [ Time Frame: First dose date up to 3 years ]
  3. Objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) [ Time Frame: Up to 6 months ]
    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) [ Time Frame: Up to 3 years ]
    PFS is defined as the time from the date of dose initiation until the earliest date of documented disease progression, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first.

  2. Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) [ Time Frame: Up to 3 years ]
    DOR is defined as time from first documentation of CR or PR to the earliest date of documented disease progression, per RECIST version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment.

  3. Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) [ Time Frame: Up to 3 years ]
    OS is defined as time from date of dose initiation to death from any cause.

  4. Serum Concentration for Magrolimab [ Time Frame: Up to end of treatment (approximately 3 years) ]
  5. Percentage of Participants who Developed Anti-Magrolimab Antibodies [ Time Frame: Up to end of treatment (approximately 3 years) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Individual must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Adequate blood counts
  • Adequate renal function
  • Adequate liver function
  • Pretreatment blood cross-match completed
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
  • Measurable disease according to RECIST version 1.1
  • Individuals must be willing to provide baseline tumor tissue from a core or excisional biopsy (fine needle aspirate is not adequate).

Cohort-Specific Inclusion Criteria:

  • Safety Run-in Cohort 1: Individuals with metastatic advanced solid tumors who have had at least 1 prior line of systemic anticancer therapy (metastatic non-small cell lung cancer (mNSCLC) and metastatic small cell lung cancer (mSCLC)) in a locally advanced/metastatic setting, or 2 prior lines of systemic anticancer therapy (metastatic urothelial cancer(mUC)) in a locally advanced/metastatic setting, and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting.
  • Phase 2 Cohort 1a (mNSCLC): Individuals with NSCLC who have had treatment with platinum-based chemotherapy and/or immune checkpoint inhibitor therapy in a locally advanced/metastatic setting are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded. Individuals who were treated for epidermal growth factor receptor (EGFR), c-ros oncogene 1 (ROS1), anaplastic lymphoma kinase (ALK), neurotrophic tyrosine kinase (NTRK), or mesenchymal-epithelial transition (MET) exon 14 genomic alterations are excluded.
  • Phase 2 Cohort 1b (mUC): Individuals with UC who have had prior treatment with systemic chemotherapy and/or immune checkpoint inhibitor therapy in a locally advanced/metastatic setting are eligible. At least 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are required and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded.
  • Phase 2 Cohort 1c (mSCLC): Individuals with SCLC who have had prior treatment with platinum-based chemotherapy and/or immune checkpoint inhibitor therapy are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded.

Note: Maintenance therapies are not counted as separate lines of therapy.

Key Exclusion Criteria:

  • Positive serum pregnancy test
  • Breastfeeding female
  • Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed
  • Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed red blood cell transfusions during the 4-week period prior to screening. RBC transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria
  • History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months
  • Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient
  • Prior treatment with CD47 or signal regulatory protein alpha-targeting agents
  • Current participation in another interventional clinical trial
  • Known inherited or acquired bleeding disorders
  • Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and who are in complete remission for over 3 years
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus
  • Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.

    • Note: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone releasing hormone agonists for prostate or breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappaB ligand (RANKL) inhibitors are not criteria for exclusion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827576


Contacts
Layout table for location contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04827576    
Other Study ID Numbers: GS-US-548-5918
2020-005265-14 ( EudraCT Number )
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action