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Bile duct cancer combo trial halted early

NCT ID NCT05998447

Disease control Sponsor: Genome & Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug combination (GEN-001 plus pembrolizumab) in 10 adults with advanced bile duct cancer that had stopped responding to standard treatments. The goal was to see if the combination was safe and could shrink tumors. The trial was terminated early, so final results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Sep 2023

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer

Contacts and locations

Locations

  • Ajou University Medical Center

    Suwon, 16499, South Korea

  • Asan Medical Center

    Seoul, Seoul, 05505, South Korea

  • Korea University Guro Hospital

    Seoul, Seoul, 08308, South Korea

  • Samsung Medical Center.

    Seoul, Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, Seoul, 03722, South Korea

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