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New drug cocktail aims to outperform standard immunotherapy in bile duct cancer

NCT ID NCT07710885

Disease control Sponsor: Taiho Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This phase 3 trial tests whether a combination of two experimental drugs (futibatinib and zimberelimab) plus standard chemotherapy can help people with advanced biliary tract cancer live longer compared to current standard immunotherapy combinations. The study enrolls about 784 adults whose cancer has not been treated before and has spread or cannot be removed by surgery. Participants receive either the new drug combo or one of two approved immunotherapy regimens, all alongside chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of futibatinib, zimberelimab, gemcitabine, and cisplatin
What this could lead to
If successful, this combination could offer a new, more effective first-line treatment option for people with advanced biliary tract cancer, potentially extending survival.
What could go wrong
This is an early-stage comparison against existing treatments, and the new combination may not prove superior. Side effects from combining multiple drugs could be significant.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 784 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2031

An estimate. End dates often move.

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

18 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: 1. Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma; 2. Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC); * Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion. 3. Has radiographically measurable disease per RECIST v1.1. 4. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient. 5. Has an ECOG PS of 0 or 1 before administration of study treatment; Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria. Exclusion Criteria: 1. History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis; 2. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination; 3. Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib 4. Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

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Conditions

The condition(s) this trial relates to.

Apert syndrome autosomal dominant Parkinson disease 4 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kanagawa Cancer Center

    NOT_YET_RECRUITING

    Kanagawa, Japan

  • National Hospital Organization Kyushu Cancer Center

    RECRUITING

    Fukuoka, Japan

  • Research Site

    NOT_YET_RECRUITING

    Brisbane, Australia

  • Research Site

    NOT_YET_RECRUITING

    Melbourne, Australia

  • Research Site

    NOT_YET_RECRUITING

    Perth, Australia

  • Research Site

    NOT_YET_RECRUITING

    Sydney, Australia

  • Research Site

    NOT_YET_RECRUITING

    Aichi, Japan

  • Research Site

    NOT_YET_RECRUITING

    Fukuoka, Japan

  • Research Site

    NOT_YET_RECRUITING

    Hokkaido, Japan

  • Research Site

    NOT_YET_RECRUITING

    Miyagi, Japan

  • Research Site

    NOT_YET_RECRUITING

    Osaka, Japan

  • Research Site

    NOT_YET_RECRUITING

    Tokyo, Japan

  • Research Site

    NOT_YET_RECRUITING

    Busan, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Hwasun, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Seongnam, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Bangkok, Thailand

  • Research Site

    NOT_YET_RECRUITING

    Chiang Mai, Thailand

  • The Cancer Institute Hospital

    RECRUITING

    Tokyo, Japan

  • Toyama University Hopspital

    RECRUITING

    Toyama, Japan

  • Wakayama Medical University Hospital

    RECRUITING

    Wakayama, Japan

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