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
Recruiting