RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Elevar Therapeutics • ClinicalTrials.gov ID: NCT07359820

Registry updated: 2026-09-03

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Description

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.

Interventions

Lirafugratinib (Drug)
Lirafugratinib is an oral inhibitor of FGFR2

Eligibility criteria

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.

Conditions

FGFR2 Gene Fusion/Rearrangement Other Solid Tumors, Adult

Locations

Mayo Clinic — Phoenix, Arizona, United States
Mayo Clinic — Jacksonville, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
University of Chicago Medical Center — Chicago, Illinois, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
Institut Bergonie — Bordeaux, France
Centre Georges François Leclerc — Dijon, France
Centre Leon Berard — Lyon, France
Gustave Roussy Cancer Campus — Paris, France
Seoul National University Hospital — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
START Barcelona-Hospital HM Nou Delfos — Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz- START MADRID — Madrid, Spain
Hospital Universitario HM Sanchinarro-START MADRID-CIOCC — Madrid, Spain
Sarah Cannon Research Institute UK — London, United Kingdom
The Christie NHS Foundation — Manchester, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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