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New pill targets rare cancer gene in 30-Patient trial

NCT ID NCT07359820

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This phase 2 trial tests an oral drug called lirafugratinib in 30 adults with advanced solid tumors (excluding bile duct cancer) that have an FGFR2 gene fusion or rearrangement. Participants take the drug regularly and visit the clinic for checkups. The main goal is to see if the drug shrinks tumors and is safe.

What this could mean

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

Active substance
lirafugratinib (a targeted oral drug that blocks FGFR2)
What this could lead to
If it works, this could offer a new treatment option for people with certain hard-to-treat cancers that have an FGFR2 gene change.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The drug may cause side effects or not shrink tumors as hoped.

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 30 people

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

Started

Jun 2026

Expected to finish

Dec 2028

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: * Unresectable, locally advanced, or metastatic solid tumor (other than CCA). * Documented FGFR2 gene fusion or rearrangement 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. * Previously (\>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies. * Subject has not received prior treatment with an FGFRi. Exclusion Criteria: * An uncontrolled comorbidity. * 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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

FGFR2 gene fusion/rearrangement Other solid tumors, adult

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

    19 sites in 5 countries. 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

  • Centre Georges François Leclerc

    NOT_YET_RECRUITING

    Dijon, 21079, France

  • Centre Leon Berard

    NOT_YET_RECRUITING

    Lyon, 69373, France

  • Gustave Roussy Cancer Campus

    RECRUITING

    Paris, 94805, France

  • Hospital Universitario Fundación Jiménez Díaz- START MADRID

    RECRUITING

    Madrid, 28040, Spain

    Contact Email: •••••@•••••

  • Hospital Universitario HM Sanchinarro-START MADRID-CIOCC

    RECRUITING

    Madrid, 28050, Spain

    Contact Email: •••••@•••••

  • Institut Bergonie

    NOT_YET_RECRUITING

    Bordeaux, 33076, France

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • START Barcelona-Hospital HM Nou Delfos

    RECRUITING

    Barcelona, 08023, Spain

    Contact Email: •••••@•••••

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute UK

    NOT_YET_RECRUITING

    London, W1G 6AD, United Kingdom

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • The Christie NHS Foundation

    RECRUITING

    Manchester, M20 4GJ, United Kingdom

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

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

More trials for these conditions

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