Combination treatment for advanced biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, multicenter, open-label study evaluates the safety and efficacy of GEN-001 in combination with pembrolizumab, and potentially with mFOLFOX, for patients with advanced refractory biliary tract cancer who have not responded to prior therapies. The study includes a safety run-in phase before the main trial to assess initial safety outcomes. Eligible patients must have a confirmed diagnosis of unresectable, recurrent, or metastatic biliary tract adenocarcinoma and have progressed after one or two standard treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• Seoul National University Hospital
  Seoul, Korea, Republic of Recruiting
• Severance Hospital
  Seoul, Korea, Republic of Recruiting
• Asan Medical Center
  Seoul, Korea, Republic of Recruiting
• Samsung Medical Center.
  Seoul, Korea, Republic of Recruiting
• Korea University Guro Hospital
  Seoul, Korea, Republic of Recruiting
• Ajou University Medical Center
  Suwon, Korea, Republic of Recruiting

Study contacts

• Study coordinator: Clinical Development Team
• Email: GNC_Clinical_202@genomecom.co.kr
• Phone: +8248212451

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.