drugset / Trial / NCT07176312
Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients
Phase 2
Recruiting
80 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Jazz Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
The ZANGEA trial is a open-label, single arm, multicenter phase II trial assessing the efficacy of zanidatamab in combination with pembrolizumab and chemotherapy in patients with metastatic gastroesophageal adenocarcinoma (GEA). The patients need to be previously untreated in the palliative setting and tested positive for HER2 and PD-L1.
Timeline
- Start
- 2026-01-16
- Primary completion
- 2029-03
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zanidatamab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Zanidatamab | Monoclonal antibody | 1600 mg | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |