GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX Drug: GEN-001 Drug: pembrolizumab Drug: mFOLFOX |
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
Other Names:
Drug: mFOLFOX
mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The patient (or legally acceptable representative if applicable) provides written informed consent for the trial.
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Be ≥19 years of age on day of signing informed consent.
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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.
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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).
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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.
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Has had an allogeneic tissue/solid organ transplan
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Genome & Company
- Merck Sharp & Dohme LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- [GNC] GEN001-202