P2 Study of Lirafugratinib in Non-CCA Tumours with FGFR2 Fusion or Rearrangement
Research type
Research Study
Full title
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
IRAS ID
1013313
Contact name
Laura Alexander
Contact email
Sponsor organisation
Elevar Therapeutics, Inc.
ISRCTN Number
-
Clinicaltrials.gov Identifier
Research summary
Some cancers grow because of changes in a gene called fibroblast growth factor receptor 2 (FGFR2). These changes can cause tumour cells to grow and spread. Medicines that block FGFR2 may help slow or stop the growth of cancers with these genetic changes.
This study will test an investigational medicine called lirafugratinib (RLY-4008). Lirafugratinib is a tablet taken by mouth that is designed to specifically block the FGFR2 protein. Earlier studies have suggested that this medicine may shrink tumours in some people whose cancers contain FGFR2 changes.
The purpose of this research is to find out whether lirafugratinib can shrink tumours or slow cancer growth, and to learn more about its safety and effects on the body.
The study will include participants with advanced solid tumours (cancers that have spread or cannot be removed with surgery), excluding cholangiocarcinoma, whose tumours contain FGFR2 gene fusions or rearrangements. Participants must have previously received systemic treatment such as chemotherapy or immunotherapy but must not have received medicines that directly target FGFR before.
This is a Phase 2, open-label, single-arm study, meaning all participants will receive lirafugratinib and both doctors and participants will know which treatment is being given. Around 20 to 30 participants will take part at approximately 20 hospitals in North America, Europe and Asia.
Participants will take lirafugratinib once daily in repeating 28-day treatment cycles. Treatment will continue until disease progression or other treatment discontinuation criteria are met.
During the study, participants will attend regular clinic visits for tumour imaging, blood and urine tests, heart tests (electrocardiograms), eye examinations, and questionnaires about quality of life. Blood samples and tumour tissue will also be analysed to study FGFR2 and other biomarkers.
The study is sponsored by Elevar Therapeutics, Inc.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
26/EM/0078
Date of REC Opinion
7 May 2026
REC opinion
Further Information Favourable Opinion