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

PHASE2RecruitingINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

September 18, 2023

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Biliary Tract Cancer
Interventions
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

Trial Locations (6)

16499

RECRUITING

Ajou University Medical Center, Suwon

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center., Seoul

08308

RECRUITING

Korea University Guro Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Genome & Company

INDUSTRY