NCT07359820

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

A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Elevar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• FGFR2 Gene Fusion/Rearrangement
• Other Solid Tumors, Adult

Interventions

Type	Name	Description
DRUG	Lirafugratinib	Lirafugratinib is an oral inhibitor of FGFR2

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-09-01
• Completion: 2028-12-01
• First posted: 2026-01-22
• Last updated: 2026-04-07

Locations

19 sites across 5 countries: United States, France, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study