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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05998447
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : March 21, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Genome & Company

Study Description
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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
Biliary Tract Cancer Drug: GEN-001 Drug: Pembrolizumab Drug: mFOLFOX Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 18, 2023
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: KEYTRUDA®

Drug: mFOLFOX
mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 1 years ]
    Incidence of dose-limiting toxicity (DLT)

  2. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator. [ Time Frame: 1 years ]
    The assessment of the anti-tumor activity per cohort


Secondary Outcome Measures :
  1. Incidence of Adverse Event (AE)s and laboratory abnormalities per National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v.5.0. cohort. [ Time Frame: 1 years ]
    The assessment the overall safety and tolerability per cohort.

  2. Duration of Response (DoR) [ Time Frame: 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

  3. Progression-free Survival (PFS) [ Time Frame: 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

  4. Overall Survival (OS) [ Time Frame: 1 years ]
    the time from the start date of treatment to the date of death


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05998447


Contacts
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Contact: Clinical Development Team +8248212451 GNC_Clinical_202@genomecom.co.kr
Contact: Clinical Development +8248212451 GNC_Clinical_202@genomecom.co.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Principal Investigator: Do-Youn Oh, M.D., PhD         
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Principal Investigator: Hyejin Choi         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Principal Investigator: InKeun Park         
Samsung Medical Center. Recruiting
Seoul, Korea, Republic of, 06351
Principal Investigator: Joon Oh Park         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Principal Investigator: Sang-cheul Oh         
Ajou University Medical Center Recruiting
Suwon, Korea, Republic of, 16499
Principal Investigator: Minsuk Kwon         
Sponsors and Collaborators
Genome & Company
Merck Sharp & Dohme LLC
More Information
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Responsible Party: Genome & Company
ClinicalTrials.gov Identifier: NCT05998447    
Other Study ID Numbers: [GNC] GEN001-202
KEYNOTE-D86 ( Other Identifier: Merck Sharp & Dohme LLC )
MK-3475-D86 ( Other Identifier: Merck Sharp & Dohme LLC )
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: March 21, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
 Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action