NCT05998447TerminatedPhase 2
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
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Reason given: Sponsor decision
Brief summary (registry, in English)
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
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 1 Aug 2023
- Start date
- 18 Sept 2023
- Primary completion date
- 26 Nov 2024
- Lead sponsor
- Genome & Company
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05998447
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- 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.
Other
- Has had an allogeneic tissue/solid organ transplan
Who the study is looking for
- 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)
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital | Seoul | South Korea | Unknown status |
| Severance hospital | Seoul | South Korea | Unknown status |
| Seoul National University Hospital | Seoul | South Korea | Unknown status |
| Samsung Medical Center | Seoul | South Korea | Unknown status |
| Ajou University Medical Center | Suwon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.