Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
Conditions
Keywords
ALX148, CD47, SIRPα, Gastric, Gastroesophageal, GEJ, HER2 positive, Ramucirumab, Evorpacept
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.
Detailed description
This is a randomized phase 2 (open-label) / 3 (blinded), 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. The Sponsor has decided not to proceed with the Phase 3 portion of the study due to strategic considerations.
Interventions
IV Q2W
DRUGTrastuzumab
IV Q2W
DRUGRamucirumab
IV Q2W
DRUGPaclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Sponsors
Eli Lilly and Company
ALX Oncology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Phase 2 is Open Label; Phase 3 is blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 central nervous system (CNS) metastases or leptomeningeal disease requiring steroids. * Prior treatment with any anti-CD47 or anti-SIRPα agent. * Prior treatment with ramucirumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2 | Last randomized patient on study at least 16 weeks | Percentage of patients with objective response per RECIST 1.1 |
| Phase 3 | From the date of randomization to the date of death (due to any cause), up to 36 months postdose | Overall Survival |
Countries
Australia, Belgium, Czechia, France, Italy, Japan, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed