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New targeted pill shows promise for Hard-to-Treat bile duct cancers

NCT ID NCT04526106

Disease control Sponsor: Elevar Therapeutics 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new oral drug called RLY-4008 in 490 adults with advanced bile duct cancer or other solid tumors that have specific FGFR2 gene changes. The drug is designed to block the FGFR2 protein, which can drive cancer growth. The trial aimed to find the safest dose and see if the drug shrinks tumors.

What this could mean

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

Active substance
RLY-4008 (a targeted oral drug that blocks FGFR2 protein)
What this could lead to
If successful, this could lead to a new treatment option for people with bile duct cancer or other solid tumors that have specific FGFR2 gene changes.
What could go wrong
This is an early-phase trial (Phase 1/2), so the drug may not work as hoped or could cause side effects. 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

490 people

The number who actually took part.

Started

Sep 2020

Finished

Sep 2025

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.

Key Inclusion Criteria * Histologically or cytologically confirmed unresectable or metastatic solid tumor * Documented FGFR2 gene fusion, mutation, or amplification per local testing of blood and/or tumor * Patient must have measurable disease per RECIST v1.1 * Patient has ECOG performance status of 0-1 * Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy * Part 2 dose expansion patients with Cholangiocarcinoma: * Group 1: CCA patients with an FGFR2 fusion previously treated with an FGFRi * Group 2: CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi * Group 6: CCA patients with an FGFR2 fusion with no prior chemotherapy and not previously treated with an FGFRi. Prior adjuvant/neo-adjuvant treatment completed \>6 months before enrollment is acceptable. Up to 2 cycles of palliative chemotherapy are allowed during screening * Group 7: CCA patients with an FGFR2 mutation or amplification and not previously treated with an FGFRi. Note: For Group 7, patients with confirmed diagnosis of unresectable or metastatic CCA with an FGFR2 fusion are not eligible. * Part 2 dose expansion patients with other solid tumors (NOT Cholangiocarcinoma): * Group 3: Non-CCA patients with an FGFR2 fusion and not previously treated with an FGFRi. * Group 4: Non-CCA patients with an FGFR2 amplification and not previously treated with an FGFRi. * Group 5: Non-CCA patients with an FGFR2 mutation and not previously treated with an FGFRi * Part 3 extension: o CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi * Part 4: * Patient is receiving RLY-4008 on RLY-4008-101 study and benefiting from treatment as assessed by the investigator. Key Exclusion Criteria * Parts 1, 2, and 3 * Ongoing, clinically significant FGFRi-induced retinal detachment or an ongoing clinically significant corneal or retinal disorder * Patient does not have adequate organ function (defined in protocol) * Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol). * QT interval corrected using Fridericia\'s formula (QTcF) \> 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome * Clinically significant, uncontrolled cardiovascular disease * CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms * Part 4: * Patient has permanently discontinued treatment with RLY-4008 for any reason before enrolling into Part 4.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma intrahepatic cholangiocarcinoma neoplasm

As listed by the trial registrant

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

Cholangiocarcinoma FGFR2 amplification FGFR2 gene activation FGFR2 gene fusion/rearrangement FGFR2 gene mutation FGFR2 gene translocation Intrahepatic cholangiocarcinoma Other solid tumors, adult

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Centre Georges François Leclerc

    Dijon, 21079, France

  • Centre Leon Berard

    Lyon, 69373, France

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Clinica de Universidad de Navarra

    Pamplona, 31008, Spain

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Gustave Roussy Cancer Campus

    Paris, 94805, France

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Fundación Jiménez Díaz- START MADRID

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro-START MADRID-CIOCC

    Madrid, 28050, Spain

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112, United States

  • Icon Cancer Care South Brisbane

    South Brisbane, 4101, Australia

  • Institut Bergonie

    Bordeaux, 33076, France

  • Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Karolinska University Hospital

    Stockholm, 17176, Sweden

  • LMU Klinikum, Campus Grosshadern

    Munich, 81377, Germany

  • Linear Clinical Research Ltd

    Nedlands, 6009, Australia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • National Cancer Center Singapore

    Singapore, 169610, Singapore

  • Netherlands Cancer institute

    Amsterdam, 1066 CX, Netherlands

  • Queen Mary Hospital

    Hong Kong, 999077, Hong Kong

  • START Barcelona-Hospital HM Nou Delfos

    Barcelona, 08023, Spain

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute UK

    London, W1G 6AD, United Kingdom

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • St. Vincent's Hosptial Sydney

    Darlinghurst, 2010, Australia

  • Taussig Cancer Institute Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Texas Oncology

    Dallas, Texas, 75246, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158, United States

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA, United Kingdom

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322, United States

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