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

Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998447
• Other study ID #: [GNC] GEN001-202
• Secondary ID: KEYNOTE-D86MK-34
• Status: Recruiting
• Phase: Phase 2
• Start date: September 18, 2023
• Est. completion date: October 2026

Study information

• Verified date: March 2024
• Source: Genome & Company
• Contact: Clinical Development Team
• Phone: +8248212451
• Email: GNC_Clinical_202[@]genomecom.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• GEN-001
The capsules taken by mouth. Each capsule will contain = 3x10^11 colony-forming units (CFU)
• Pembrolizumab
200 mg given by intravenous (IV) infusion once every 3 weeks
• mFOLFOX
mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center.	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou University Medical Center	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Genome & Company	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 years
Primary	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	1 years
Secondary	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.	1 years
Secondary	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	1 years
Secondary	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	1 years
Secondary	Overall Survival (OS)	the time from the start date of treatment to the date of death	1 years