NCT05998447

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

A Phase II Study to Evaluate the Safety and the Efficacy of GEN-001 in Combination With Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Genome & Company · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	GEN-001	The capsules taken by mouth. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU)
DRUG	Pembrolizumab	200 mg given by intravenous (IV) infusion once every 3 weeks
DRUG	mFOLFOX	mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3

Timeline

• Start date: 2023-09-18
• Primary completion: 2024-11-26
• Completion: 2024-11-26
• First posted: 2023-08-21
• Last updated: 2025-12-16

Locations

6 sites across 1 country: South Korea