GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
- Conditions
- Biliary Tract Cancer
- Interventions
- Registration Number
- NCT05998447
- Lead Sponsor
- Genome & Company
- 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 148
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX mFOLFOX Drug: GEN-001 Drug: pembrolizumab Drug: mFOLFOX GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX Pembrolizumab Drug: GEN-001 Drug: pembrolizumab Drug: mFOLFOX GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX GEN-001 Drug: GEN-001 Drug: pembrolizumab Drug: mFOLFOX
- Primary Outcome Measures
Name Time Method The recommended Phase 2 dose (RP2D) of GEN-001 in patients with advanced refractory biliary tract cancer (BTC), when administered as combined with pembrolizumab or as combined with pembrolizumab and mFOLFOX. 1 years Incidence of dose-limiting toxicity (DLT)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator. 1 years The assessment of the anti-tumor activity per cohort
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Event (AE)s and laboratory abnormalities per National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v.5.0. cohort. 1 years The assessment the overall safety and tolerability per cohort.
Duration of Response (DoR) 1 years the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first
Progression-free Survival (PFS) 1 years the time from the start date of treatment to the date of PD by RECIST v1.1 or death due to any cause, whichever occurs first
Overall Survival (OS) 1 years the time from the start date of treatment to the date of death
Trial Locations
- Locations (6)
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center.
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Medical Center
🇰🇷Suwon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of