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

Genome & Company

Status and phase: Terminated; Phase 2

Conditions: Biliary Tract Cancer

Treatments: Drug: GEN-001; Drug: Pembrolizumab; Drug: mFOLFOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05998447

[GNC] GEN001-202

MK-3475-D86 (Other Identifier)

KEYNOTE-D86 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX

Experimental group

Description:

Drug: GEN-001 Drug: pembrolizumab Drug: mFOLFOX

Treatment:

Drug: mFOLFOX

Drug: Pembrolizumab

Drug: GEN-001