drugset / Trial / NCT05998447

GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer

NCT05998447

Phase 2 Terminated 10 enrolled Genome & Company Merck Sharp & Dohme LLC · collab
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

EvaluationDrugModalityDoseRoute
Subject GEN-001 Other / unclassified 3e+11 unknown Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications