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New pill targets bile duct cancer that resists standard treatments

NCT ID NCT05948475

Disease control Sponsor: TransThera Sciences (Nanjing), Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This Phase 3 trial tests an oral drug called tinengotinib against standard treatments chosen by the doctor for people with advanced bile duct cancer (cholangiocarcinoma) that has a specific genetic alteration (FGFR) and has stopped responding to chemotherapy and an FGFR inhibitor. The study compares how well tinengotinib controls the cancer and its side effects. Participants are randomly assigned to receive either tinengotinib or a standard chemotherapy regimen.

What this could mean

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

Active substance
tinengotinib
What this could lead to
If successful, tinengotinib could offer a new oral treatment option for people with a specific type of bile duct cancer that has stopped responding to other therapies.
What could go wrong
This is an early-stage Phase 3 trial, and the drug may not prove more effective or safer than existing options. Side effects are possible, and results may not apply to all patients.

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 200 people

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

Started

Dec 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. ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease. 3. Documentation of FGFR2 fusion/rearrangement gene status 4. Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor. Exclusion Criteria: 1. Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs. 2. Subjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment. 3. Subjects with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, including those that have previously undergone potentially curative therapy. 4. Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy. 5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval. 6. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy. 7. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening)

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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.

Cholangiocarcinoma

Contacts and locations

Locations

  • AOUI Verona - Ospedale Borgo Roma

    Verona, Italy

  • ASST Grande Ospedale Metropolitano Niguard

    Milan, Italy

  • Amsterdam UMC, location AMC

    Amsterdam, 1105 AZ, Netherlands

  • Asklepios Klinik Altona

    Hamburg, Germany

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Naples, Italy

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    Siena, Italy

  • Azienda Ospedaliera Universitaria di Parma

    Parma, Italy

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, Italy

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • Candiolo Cancer Institute - FPO IRCCS

    Candiolo, 10060, Italy

  • Centre Hospitalier Régional Universitaire de Besançon

    Besançon, France

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, France

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

    Lisbon, Portugal

  • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

    Warsaw, Poland

  • Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

    Kaohsiung City, 833401, Taiwan

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • Clinica Oncologica, Ospedali Riuniti Umberto 1

    Ancona, Italy

  • Clinica Universidad de Navarra

    Madrid, Spain

  • Clinica Universidad de Navarra

    Pamplona, Spain

  • Clinique de la Sauvegarde

    Lyon, France

  • Dong-A University Hospital

    Busan, 49201, South Korea

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

  • Fundação Champalimaud

    Lisbon, Portugal

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 52727, South Korea

  • HM Hospital Universitario Madrid Sanchinarro - CIOCC

    Madrid, Spain

  • Henry Ford

    Detroit, Michigan, 48201, United States

  • Hopital Beaujon

    Clichy, France

  • Hopital Franco-Britannique - Fondation Cognacq-Jay

    Levallois-Perret, France

  • Hopital Saint Antoine

    Paris, France

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, Spain

  • Hospital Clínic de Barcelona

    Barcelona, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, Spain

  • Hospital Universitari Vall d´Hebron

    Barcelona, Spain

  • Hospital Universitario 12 de octubre

    Madrid, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Hospital Universitario Reina Sofa

    Córdoba, Spain

  • Humanitas Research Hospital

    Rozzano, Italy

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Institut Sainte Catherine - Institut du Cancer Avignon Provence

    Avignon, France

  • Institut de Cancerologie Gustave Roussy

    Villejuif, France

  • Istituto Europeo di Oncologia IRCCS

    Milan, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Italy

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Krankenhaus Nordwest gGmbH

    Frankfurt, Germany

  • Krebszentrum Reutlingen

    Baden, Germany

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, Austria

  • Ludwig-Maximilians-Universität München Kum

    München, Germany

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53202, United States

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Messino Cancer Centers

    Asheville, North Carolina, 28806, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nottingham University Hospitals NHS Trust

    Nottingham, United Kingdom

  • Ordensklinikum Linz GmbH

    Linz, Austria

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • Royal Marsden Hospital NHS

    London, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Stanford Cancer Center

    Stanford, California, 94305, United States

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tennessee Oncology- Nashville

    Nashville, Tennessee, 37203, United States

  • Texas Oncology-Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • The Christie NHS Foundation Trust - Christie Hospital

    Manchester, United Kingdom

  • The University of Chicago Hospitals

    Chicago, Illinois, 60601, United States

  • The University of Kansas Cancer Center

    Westwood, Los Angeles, California, 90024, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77002, United States

  • UCG-1st floor central

    London, United Kingdom

  • UCLA Medical Center

    Santa Monica, California, 90401, United States

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)

    Heidelberg, Germany

  • Universitair Ziekenhuis Antwerpen

    Antwerp, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • Universitair Ziekenhuis Leuven

    Leuven, Belgium

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Michigan

    Ann Arbor, Michigan, 48103, United States

  • University of Minnesota- Masonic Cancer Center, M Health Fairview

    Minneapolis, Minnesota, 55455, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75201, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37203, United States

  • Yonsei University Health System - Severance Hospital

    Seoul, 03722, South Korea

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Other studies related to the condition(s) this trial covers.