drugset / Trial / NCT05998447
GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety and efficacy of GEN-001 in combination with pembrolizumab or in combination with pembrolizumab and mFOLFOX for patients with advanced refractory BTC who have progressed after 1 or 2 prior standard therapy and are not candidates for any other standard therapy. The safety run-in phase will be conducted before the main study phase
Timeline
- Start
- 2023-09-18
- Primary completion
- 2024-11-26
- Completion
- 2024-11-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GEN-001 | Other / unclassified | 3e+11 unknown | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |