Status:
TERMINATED
GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
Lead Sponsor:
Genome & Company
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05998447
Start Date
September 18 2023
End Date
November 26 2024
Last Update
December 16 2025
Active Locations (6)
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1
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
2
Severance Hospital
Seoul, Seoul, South Korea, 03722
3
Asan Medical Center
Seoul, Seoul, South Korea, 05505
4
Samsung Medical Center.
Seoul, Seoul, South Korea, 06351