A Phase 2/3 interventional study of Evorpacept (ALX148) and Trastuzumab in Gastric Cancer, Gastroesophageal Junction Adenocarcinoma and Gastric Adenocarcinoma, sponsored by ALX Oncology Inc.. Active, not recruiting at 83 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by ALX Oncology Inc. · Phase 2/3, Interventional, and Treatment
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.
Exclusion Criteria:
Evorpacept (ALX148) 30 mg/kg every two weeks (Q2W) intravenous (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) · Drug: Trastuzumab · Drug: Ramucirumab · Drug: Paclitaxel
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 · Drug: Ramucirumab · Drug: Paclitaxel
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) · Drug: Trastuzumab · Drug: Ramucirumab · Drug: Paclitaxel
Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Drug: Ramucirumab · Drug: Paclitaxel
IV Q2W
IV Q2W
Also known as: Herceptin
IV Q2W
Also known as: Cyramza
IV Days 1, 8, and 15 of a 28-day cycle
Also known as: Taxol
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
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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ALX Oncology Inc.