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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
127
Phase 2
Percentage of patients with objective response per RECIST 1.1
Time frame: Last randomized patient on study at least 16 weeks
Phase 3
Overall Survival
Time frame: From the date of randomization to the date of death (due to any cause), up to 36 months postdose
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Leuven, Belgium
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