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Evorpacept in Advanced HER2-Overexpressing Gastric/GEJ Adenocarcinoma (ASPEN-06)
NCT05002127Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2022
- Primary completion
- May 2024
- Countries
- 12
- Sponsor
- ALX Oncology
- Modality
- Fc-Fusion Proteins
- Drugs
- evorpacept
- Conditions
- gastric adenocarcinomagastroesophageal junction adenocarcinoma
01
Overview
Phase 3, randomised, double-blind trial of evorpacept in gastric adenocarcinoma and gastroesophageal junction adenocarcinoma (4 arms), sponsored by ALX Oncology. Primary endpoints: Phase 2 Primary Endpoint at 16 weeks and Overall Survival at 36 months. Started Jan 2022; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Phase 2 - Arm A
Evorpacept + Trastuzumab + Ramucirumab + Paclitaxel
Phase 2 - Arm B
Trastuzumab + Ramucirumab + Paclitaxel
Phase 3 - Arm A
Evorpacept + Trastuzumab + Ramucirumab + Paclitaxel
Phase 3 - Arm B
Ramucirumab + Paclitaxel
03
Who it enrols
Adult patients with HER2-overexpressing advanced or metastatic gastric/GEJ adenocarcinoma who progressed on prior HER2-directed therapy and fluoropyrimidine/platinum chemotherapy, excluding those with symptomatic CNS metastases or prior ramucirumab/CD47/SIRPα treatment.
04
Endpoints
Primary
Phase 2 Primary Endpoint
Overall Survival
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