Back to resultsGEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
Primary Purpose
Biliary Tract Cancer
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GEN-001
Pembrolizumab
mFOLFOX
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer
Eligibility 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
Sites / Locations
- Seoul National University HospitalRecruiting
- Severance HospitalRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical Center.Recruiting
- Korea University Guro HospitalRecruiting
- Ajou University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
Arm Description
Drug: GEN-001 Drug: pembrolizumab Drug: mFOLFOX
Outcomes
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.
Incidence of dose-limiting toxicity (DLT)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator.
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.
The assessment the overall safety and tolerability per cohort.
Duration of Response (DoR)
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)
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)
the time from the start date of treatment to the date of death
Full Information
NCT ID
NCT05998447
First Posted
August 1, 2023
Last Updated
October 15, 2023
Sponsor
Genome & Company
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05998447
Brief Title
GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genome & Company
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
Arm Type
Experimental
Arm Description
Drug: GEN-001
Drug: pembrolizumab
Drug: mFOLFOX
Intervention Type
Drug
Intervention Name(s)
GEN-001
Intervention Description
The capsules taken by mouth. Each capsule will contain ≥ 3x10^11 colony-forming units (CFU)
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
200 mg given by intravenous (IV) infusion once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
mFOLFOX
Intervention Description
mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3
Primary Outcome Measure Information:
Title
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.
Description
Incidence of dose-limiting toxicity (DLT)
Time Frame
1 years
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator.
Description
The assessment of the anti-tumor activity per cohort
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Incidence of Adverse Event (AE)s and laboratory abnormalities per National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v.5.0. cohort.
Description
The assessment the overall safety and tolerability per cohort.
Time Frame
1 years
Title
Duration of Response (DoR)
Description
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
Time Frame
1 years
Title
Progression-free Survival (PFS)
Description
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
Time Frame
1 years
Title
Overall Survival (OS)
Description
the time from the start date of treatment to the date of death
Time Frame
1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Development Team
Phone
+8248212451
Email
GNC_Clinical_202@genomecom.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Development
Phone
+8248212451
Email
GNC_Clinical_202@genomecom.co.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do-Youn Oh, M.D., PhD
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyejin Choi
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
InKeun Park
Facility Name
Samsung Medical Center.
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Oh Park
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-cheul Oh
Facility Name
Ajou University Medical Center
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minsuk Kwon
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
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