ASPEN-06 / AT148006
ASPEN-06 / AT148006: A Study of Evorpacept (ALX148) in Patients with Advanced HER2+ Gastric Cancer
Trial summary:
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.
Receptor status / problem studied:
Inclusion criteria
1) 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).
2) Adequate Bone Marrow Function.
3) Adequate Renal & Liver Function.
4) Adequate Performance Status.
Exclusion criteria
1) Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
2) Prior treatment with any anti-CD47 or anti-SIRPα agent.
3) Prior treatment with ramucirumab.
Trial Title
ASPEN-06 / AT148006
Diagnosis
Gastric / gastroesophageal cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
II/III