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Lirafugratinib for Solid Tumors with FGFR2 Fusion or Rearrangement

This study is testing a drug called lirafugratinib in adults with certain advanced solid tumors that have an FGFR2 gene fusion or rearrangement. These are tumors that have already been treated with other therapies and cannot be removed by surgery. Lirafugratinib is a pill that targets the FGFR2 protein. Researchers want to see how many patients respond to lirafugratinib and if it is safe. To join, you must have measurable disease and a good performance status. The study plans to enroll 30 participants.

Study design
This is an interventional study with a planned enrollment of 30 adult participants.
What's involved
You will take lirafugratinib regularly, visit the clinic for checkups and tests, and keep a diary of your doses.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured approximately every 8 weeks during treatment and every 12 weeks after the last dose for about 36 months if your disease has not progressed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07359820

A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

Recruiting
PHASE2Ages 18+InterventionalTreatment
Elevar Therapeutics
~30 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:Lirafugratinib

At a glance

Recruiting sites
12 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1.
Measured over Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.

Conditions

FGFR2 Gene Fusion/Rearrangement
Other Solid Tumors, Adult

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NCT07359820

Where you'd take part

This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Gustave Roussy Cancer Campus

    Paris, Francestudy coordinator listed

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz- START MADRID

    Madrid, Spainstudy coordinator listed

    Recruiting

  • Hospital Universitario HM Sanchinarro-START MADRID-CIOCC

    Madrid, Spainstudy coordinator listed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

  • Samsung Medical Center

    Seoul, South Koreastudy coordinator listed

    Recruiting

  • Seoul National University Hospital

    Seoul, South Koreastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Elevar Therapeutics
[email protected]
+1 (385) 276-3800
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1.Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.