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Trial Title:
GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
NCT ID:
NCT05998447
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GEN-001
Description:
The capsules taken by mouth. Each capsule will contain ≥ 3x10^11 colony-forming units
(CFU)
Arm group label:
GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
200 mg given by intravenous (IV) infusion once every 3 weeks
Arm group label:
GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
Other name:
KEYTRUDA®
Intervention type:
Drug
Intervention name:
mFOLFOX
Description:
mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3
Arm group label:
GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
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
Criteria for 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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Do-Youn Oh, M.D., PhD
Email:
Principal Investigator
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Hyejin Choi
Email:
Principal Investigator
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
InKeun Park
Email:
Principal Investigator
Facility:
Name:
Samsung Medical Center.
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Joon Oh Park
Email:
Principal Investigator
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Sang-cheul Oh
Email:
Principal Investigator
Facility:
Name:
Ajou University Medical Center
Address:
City:
Suwon
Zip:
16499
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Minsuk Kwon
Email:
Principal Investigator
Start date:
September 18, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
Genome & Company
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Genome & Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05998447
