Overview

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

Status:
Recruiting
Trial end date:
2026-10-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genome & Company
Collaborator:
Merck Sharp & Dohme LLC
Treatments:
Pembrolizumab
Criteria
Inclusion Criteria:

- The patient (or legally acceptable representative if applicable) provides written
informed consent for the trial.

- Be ≥19 years of age on day of signing informed consent.

- Patient with histologically or cytologically confirmed diagnosis of unresectable,
recurrent, or metastatic advanced biliary tract adenocarcinoma of the gallbladder or
biliary tree (either intrahepatic or extrahepatic cholangiocarcinoma)

Exclusion Criteria:

- A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment.
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required.

- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor (Cohort 1
only), and was discontinued from the previous IO therapy due to a Grade 3 or higher
immune-related AE (irAE) (Cohort 2 and Cohort 3).

- Is currently participating and receiving study treatments or has participated in a
study of an investigational agent and received the study therapy or has used an
investigational device within 4 weeks prior to the first dose of study treatment.

- Has had an allogeneic tissue/solid organ transplan