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Clinical Trials in the UK / NCT07359820
Recruiting Phase 2

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

NCT07359820 · tracked via the Priya Life Science UK tracker
Sponsor
Elevar Therapeutics
Phase
Phase 2
Started
2026-06-04
Last updated
2026-09-03

Condition(s) studied

FGFR2 Gene Fusion/RearrangementOther Solid Tumors, Adult

Investigational drug(s) / intervention(s)

Lirafugratinib

Lirafugratinib: Lirafugratinib is an oral inhibitor of FGFR2

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Mayo Clinic Phoenix Arizona Not Yet Recruiting
Mayo Clinic Jacksonville Florida Not Yet Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Mayo Clinic Rochester Minnesota Not Yet Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
The University of Texas M.D. Anderson Cancer Center Houston Texas Recruiting
Institut Bergonie Bordeaux France Not Yet Recruiting
Centre Georges François Leclerc Dijon France Not Yet Recruiting
Centre Leon Berard Lyon France Not Yet Recruiting
Gustave Roussy Cancer Campus Paris France Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
START Barcelona-Hospital HM Nou Delfos Barcelona Spain Recruiting
Hospital Universitario Fundación Jiménez Díaz- START MADRID Madrid Spain Recruiting
Hospital Universitario HM Sanchinarro-START MADRID-CIOCC Madrid Spain Recruiting
Sarah Cannon Research Institute UK London United Kingdom Not Yet Recruiting
The Christie NHS Foundation Manchester United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07359820 on ClinicalTrials.gov ↗ ← All trials in the UK