drugset / Trial / NCT06282575
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.
Timeline
- Start
- 2024-07-19
- Primary completion
- 2028-12-01
- Completion
- 2030-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Subject | Zanidatamab | Monoclonal antibody | — | Intravenous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Gemcitabine | Small molecule | — | Intravenous |