NCT07359820RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Jan 2026
- Start date
- 4 Jun 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Elevar Therapeutics
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07359820
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 4 Jun 2026 to the primary completion date, Sept 2027
- 19 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
- Clinically significant, uncontrolled cardiovascular disease.
Lab values
- 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.
Other
- An uncontrolled comorbidity.
- Patient does not have adequate organ function (defined in protocol).
- CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| START Barcelona Hospital HM Nou Delfos Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro - START Madrid CIOCC Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz- START MADRID Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Gustave Roussy Cancer Campus Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Sarah Cannon Research Institute UK Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| The Christie NHS Foundation Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The University of Texas M. D. Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Phoenix | United States | Not yet recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Not yet recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.