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A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)

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ClinicalTrials.gov Identifier: NCT05002127
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : January 25, 2023
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
ALX Oncology Inc.

Study Description
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Brief Summary:
A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal Junction Adenocarcinoma Gastric Adenocarcinoma Drug: Evorpacept (ALX148) Drug: Trastuzumab Drug: Ramucirumab Drug: Paclitaxel Phase 2 Phase 3

Detailed Description:
This is a randomized phase 2 (open-label) / 3 (double-blind), international, multi-center study of patients with metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy (2nd-line or 3rd-line). Approximately 450 adult patients are expected to be enrolled in the study across both phases.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Phase 2 is Open Label; Phase 3 is blinded
Primary Purpose: Treatment
Official Title: A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
Actual Study Start Date : January 15, 2022
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : August 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Ramucirumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 2 - Arm A
Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
 Drug: Evorpacept (ALX148)
IV Q2W

Drug: Trastuzumab
IV Q2W
Other Name: Herceptin

Drug: Ramucirumab
IV Q2W
Other Name: Cyramza

Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Name: Taxol
Active Comparator: Phase 2 - Arm B
Trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
 Drug: Trastuzumab
IV Q2W
Other Name: Herceptin

Drug: Ramucirumab
IV Q2W
Other Name: Cyramza

Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Name: Taxol
Experimental: Phase 3 - Arm A
Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
 Drug: Evorpacept (ALX148)
IV Q2W

Drug: Trastuzumab
IV Q2W
Other Name: Herceptin

Drug: Ramucirumab
IV Q2W
Other Name: Cyramza

Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Name: Taxol
Active Comparator: Phase 3 - Arm B
Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
 Drug: Ramucirumab
IV Q2W
Other Name: Cyramza

Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Name: Taxol


Outcome Measures
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Primary Outcome Measures :
  1. Phase 2 [ Time Frame: Last randomized patient on study at least 16 weeks ]
    Percentage of patients with objective response per RECIST 1.1

  2. Phase 3 [ Time Frame: From the date of randomization to the date of death (due to any cause), up to 36 months postdose ]
    Overall Survival


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line)
  • Adequate Bone Marrow Function.
  • Adequate Renal & Liver Function.
  • Adequate Performance Status

Exclusion Criteria:

  • Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
  • Prior treatment with any anti-CD47 or anti-SIRPα agent.
  • Prior treatment with ramucirumab.
Contacts and Locations
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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): NCT05002127


Contacts
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Contact: Philip Fanning, PhD 650-466-7125 info@alxoncology.com
Contact: Sophia Randolph, MD, PhD 650-466-7125 info@alxoncology.com

Locations
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Sponsors and Collaborators
ALX Oncology Inc.
Eli Lilly and Company
More Information
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Responsible Party: ALX Oncology Inc.
ClinicalTrials.gov Identifier: NCT05002127    
Other Study ID Numbers: AT148006
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ALX Oncology Inc.:
ALX148
CD47
SIRPα
Gastric
Gastroesophageal
 GEJ
HER2 positive
Ramucirumab
Evorpacept
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Head and Neck Neoplasms
Esophageal Diseases
Paclitaxel
Trastuzumab
Ramucirumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological