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NCT07359820PHASE2Recruiting

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

Elevar Therapeutics

Start Date

6/4/2026

Completion Date

12/1/2028

Summary

The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: * Take lirafugratinib regularly as instructed by their study doctor. * Visit the clinic as instructed for checkups and tests. * Keep a diary recording each time a dose of lirafugratinib is taken.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Lirafugratinib

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Conditions

FGFR2 Gene Fusion/RearrangementOther Solid Tumors, Adult

Locations

Mayo Clinic

Phoenix, Arizona 85054

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas 77030

United States

Institut Bergonie

Bordeaux, 33076

France

Centre Georges François Leclerc

Dijon, 21079

France

Centre Leon Berard

Lyon, 69373

France

Gustave Roussy Cancer Campus

Paris, 94805

France

Seoul National University Hospital

Seoul, 03080

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

START Barcelona-Hospital HM Nou Delfos

Barcelona, 08023

Spain

Hospital Universitario Fundación Jiménez Díaz- START MADRID

Madrid, 28040

Spain

Hospital Universitario HM Sanchinarro-START MADRID-CIOCC

Madrid, 28050

Spain

University College Hospital (NIHR UCLH Clinical Research Facility)

London, NW1 2BU

United Kingdom

Sarah Cannon Research Institute UK

London, W1G 6AD

United Kingdom

The Christie NHS Foundation

Manchester, M20 4GJ

United Kingdom