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New targeted drug shows promise for rare bile duct cancer

NCT ID NCT05727176

Disease control Sponsor: Taiho Oncology, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 5 times

Summary

This Phase 2 trial is testing two doses (20 mg and 16 mg) of the oral drug futibatinib in 120 people with advanced bile duct cancer that has specific FGFR2 gene changes. Participants must have already tried standard chemotherapy. The study aims to see which dose works better at shrinking tumors and controlling the disease, while also checking safety. It is currently recruiting at multiple sites worldwide.

What this could mean

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

Active substance
Futibatinib (TAS-120), an oral targeted therapy
What this could lead to
If successful, this could confirm a new standard dose for futibatinib and offer a treatment option for people with advanced bile duct cancer that has FGFR2 gene changes.
What could go wrong
This is a Phase 2 trial with only 120 participants, so results are still early. The drug may not work for everyone, and side effects like high phosphate levels or eye issues are possible.

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

About 120 people

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

Started

Jul 2023

Expected to finish

Dec 2026

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. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma. 2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement 3. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA 4. Documentation of radiographic disease progression on the most recent prior therapy 5. Measurable disease 6. performance status 0 or 1 7. Adequate organ function Exclusion Criteria: 1. History or current evidence of calcium and phosphate homeostasis disorder 2. Current evidence of clinically significant retinal disorder 3. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib: 1. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks 2. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks 3. Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer 4. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter. 5. Patients with prior FGFR-directed therapy 4. A serious illness or medical condition(s) including (but not limited to) the following: 1. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month 2. Known acute systemic infection 3. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV New York Heart Association \[NYHA\] Classification) within the previous 2 months; if \>2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms 4. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib. 5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study. 5. Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment. 6. Pregnant or lactating female. 7. Known hypersensitivity or severe reaction to futibatinib or its excipients.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma

As listed by the trial registrant

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

Advanced cholangiocarcinoma FGFR2 fusions Gene rearrangement

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOUI Verona - Ospedale Borgo Roma

    COMPLETED

    Verona, 37134, Italy

  • Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center

    COMPLETED

    Melbourne, Victoria, 3004, Australia

  • CEMIC

    COMPLETED

    CABA, 1431, Argentina

  • CHA Bundang Medical Center

    COMPLETED

    Seongnam, 13532, South Korea

  • Center for Oncology and Blood Disorders

    WITHDRAWN

    Houston, Texas, 77030, United States

  • Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria

    WITHDRAWN

    Lisbon, 1649-035, Portugal

  • Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli

    WITHDRAWN

    Lublin, 20-0920, Poland

  • Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie

    COMPLETED

    Warsaw, 02-034, Poland

  • Clinica Universidad de Navarra

    COMPLETED

    Pamplona, 31008, Spain

  • Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)

    WITHDRAWN

    Madrid, 28027, Spain

  • Dong-A University Hospital

    WITHDRAWN

    Busan, 49201, South Korea

  • Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.

    COMPLETED

    Otwock, 05-400, Poland

  • Fundacao Antonio Prudente - A.C.Camargo Cancer Center

    COMPLETED

    São Paulo, 01508-010, Brazil

  • Fundação Champalimaud

    WITHDRAWN

    Lisbon, 1400-038, Portugal

  • Gabrail Cancer Center Research

    WITHDRAWN

    Canton, Ohio, 44718, United States

  • Grand River Hospital - Grand River Regional Cancer Centre (GRRCC)

    WITHDRAWN

    Kitchener, OH, N2G 1G3, Canada

  • Guangdong Provincial People's Hospitall

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Gyeongsang National University Hospital

    WITHDRAWN

    Jinju, 52727, South Korea

  • Harbin Medical University - Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, China

  • Henry Ford Health System

    COMPLETED

    Detroit, Michigan, 48202, United States

  • Hospital Britanico

    COMPLETED

    Buenos Aires, AEB1280, Argentina

  • Hospital Erasto Gaertner

    WITHDRAWN

    Curitiba, 81520-060, Brazil

  • Hospital General Universitario Gregorio Maranon

    COMPLETED

    Madrid, 28007, Spain

  • Hospital Universitario 12 de octubre

    COMPLETED

    Madrid, 28043, Spain

  • Hospital Universitario Fundación Jimenez Díaz

    COMPLETED

    Madrid, 28040, Spain

  • Hospital Vall d'Hebron

    COMPLETED

    Barcelona, 08035, Spain

  • Hospital de Base de Sao Jose do Rio Preto

    COMPLETED

    São José do Rio Preto, 15090-000, Brazil

  • IOP - Instituto de Oncologia do Parana

    COMPLETED

    Curitiba, 80530-010, Brazil

  • IRCCS Humanitas Research Hospital

    COMPLETED

    Rozzano, 20089, Italy

  • Inje University Haeundae Paik Hospital

    COMPLETED

    Busan, 48108, South Korea

  • Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals

    COMPLETED

    Barcelona, 08908, Spain

  • Instituto do Cancer do Estado de Sao Paulo

    COMPLETED

    Cerqueira César, 01246-000, Brazil

  • Jiangsu Provance Hospital

    RECRUITING

    Nanjing, Jiangsu, 212028, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, 130028, China

  • Kyungpook National University Hospital

    WITHDRAWN

    Daegu, 41944, South Korea

  • McGill University Health Center

    WITHDRAWN

    Montreal, Quebec, H4A 3J1, Canada

  • Nagasaki University Hospital

    WITHDRAWN

    Nagasaki, 852-8501, Japan

  • Nagoya University Hospital

    COMPLETED

    Nagoya, 466-8560, Japan

  • National Cancer Center Hospital East

    COMPLETED

    Kashiwa-Shi, 277-0882, Japan

  • Osaka Metropolitan University Hospital

    COMPLETED

    Osaka-Fu, 558-8585, Japan

  • Policlinico S. Orsola-Malpighi

    COMPLETED

    Bologna, 40138, Italy

  • Sanatorio de la Mujer

    WITHDRAWN

    Rosario, S2013, Argentina

  • Shandong University - Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanghai Gobroad Cancer Hospital China Pharmaceutical University

    RECRUITING

    Shanghai, 200123, China

  • Sir Run Run Shaw Hospital, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • St John of God Subiaco Hospital

    COMPLETED

    Subiaco, Western Australia, 6008, Australia

  • St Vincent's Hospital Sydney - The Kinghorn Cancer Centre

    COMPLETED

    Sydney, New South Wales, 2010, Australia

  • Sunnybrook Health Sciences Center

    WITHDRAWN

    Toronto, Ohio, M4M 3N5, Canada

  • Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika

    WITHDRAWN

    Koszalin, 75-581, Poland

  • Tampa General Hospital Cancer Institute

    WITHDRAWN

    Tampa, Florida, 33606, United States

  • Texas Onc Methodist (Charlton)

    COMPLETED

    Dallas, Texas, 75237, United States

  • Texas Oncology

    COMPLETED

    Abilene, Texas, 79606-5208, United States

  • Texas Oncology - Northeast

    COMPLETED

    Denton, Texas, 76201, United States

  • Texas Oncology Methodist DFW

    COMPLETED

    Dallas, Texas, 75230, United States

  • The Catholic University of Korea, St. Mary's Hospital

    COMPLETED

    Seoul, 06591, South Korea

  • The Chinese University of Hong Kong Prince of Wales Hospital

    COMPLETED

    New Territories, 999077, Hong Kong

  • The Liver Institute at Methodist Dallas Medical Center

    COMPLETED

    Dallas, Texas, 75203, United States

  • The University of Hong Kong

    WITHDRAWN

    Hong Kong Island, 999077, Hong Kong

  • Tohoku University Hospital

    WITHDRAWN

    Sendai, Miyagi, 980-8574, Japan

  • Tongji University Shanghai East Hospital

    RECRUITING

    Shanghai, China

  • University of California San Diego UCSD - Moores Cancer Center

    COMPLETED

    La Jolla, California, 92093, United States

  • University of Toronto

    COMPLETED

    Toronto, OH, M5G 2M9, Canada

  • West China Hospital- Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Yonsei University Health System - Severance Hospital

    COMPLETED

    Seoul, 03722, South Korea

  • Zhongahan Hospital Fudan unversity

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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