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 (47)

National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
Farrer Park
Farrer Park Recruiting