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

NCT05998447 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-16

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2024-11-26
Completion
2024-11-26

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05998447 on ClinicalTrials.gov