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

Recruiting now · Phase 2

Conditions studied: FGFR2 Gene Fusion/Rearrangement, Other Solid Tumors, Adult

In brief

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.

Key facts

Study ID

NCT07359820

Run by

Elevar Therapeutics

People needed

30

Starts

2026-06-04

Expected to finish

2028-12-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Gustave Roussy Cancer Campus — Paris, France
• 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
• University College Hospital (NIHR UCLH Clinical Research Facility) — London, United Kingdom
• Sarah Cannon Research Institute UK — London, United Kingdom
• Mayo Clinic — Phoenix, Arizona, United States
• The Christie NHS Foundation — Manchester, United Kingdom
• Mayo Clinic — Jacksonville, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Institut Bergonie — Bordeaux, France
• Centre Georges François Leclerc — Dijon, France
• Centre Leon Berard — Lyon, France

Full record on ClinicalTrials.gov

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