A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)

Trial number:
NCT05002127
Trial phase:
2, 3
Study type:
Immunotherapy, Targeted therapy, Chemotherapy
Overall status:
Recruiting

Study start date

January, 2022

Scientific title

A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

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.

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

Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.Prior treatment with any anti-CD47 or anti-SIRPα agent. Prior treatment with ramucirumab.

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label), Masking description: Phase 2 is Open Label; Phase 3 is blinded,

Conditions

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma

Other study ID numbers

AT148006

Choose trial site (17)

National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting