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

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.

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.

Phase 2 is Open Label; Phase 3 is blinded