Actively Recruiting
A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Led by Elevar Therapeutics · Updated on 2026-05-01
30
Participants Needed
19
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with unresectable, locally advanced, or metastatic solid tumors other than cholangiocarcinoma
- Documented FGFR2 gene fusion or rearrangement confirmed by local testing of blood and/or tumor
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Previously treated more than 30 days ago with at least one line of systemic therapy including chemotherapy, immunotherapy, radiation, or other approved treatments
- No prior treatment with an FGFR inhibitor
You will not qualify if you...
- Uncontrolled medical conditions
- Inadequate organ function as defined in the study protocol
- Active infections including HIV, hepatitis B, or hepatitis C, except well-controlled hepatitis B
- QT interval corrected using Fridericia's formula (QTcF) greater than 480 milliseconds or history/family history of prolonged QT syndrome or related arrhythmias
- Clinically significant uncontrolled heart disease
- Central nervous system metastases or primary brain tumors causing progressive neurological symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
7
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
Institut Bergonie
Bordeaux, France, 33076
Not Yet Recruiting
9
Centre Georges François Leclerc
Dijon, France, 21079
Not Yet Recruiting
10
Centre Leon Berard
Lyon, France, 69373
Not Yet Recruiting
11
Gustave Roussy Cancer Campus
Paris, France, 94805
Not Yet Recruiting
12
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
13
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
14
START Barcelona-Hospital HM Nou Delfos
Barcelona, Spain, 08023
Not Yet Recruiting
15
Hospital Universitario Fundación Jiménez Díaz- START MADRID
Madrid, Spain, 28040
Not Yet Recruiting
16
Hospital Universitario HM Sanchinarro-START MADRID-CIOCC
Madrid, Spain, 28050
Not Yet Recruiting
17
University College Hospital (NIHR UCLH Clinical Research Facility)
London, United Kingdom, NW1 2BU
Not Yet Recruiting
18
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
Not Yet Recruiting
19
The Christie NHS Foundation
Manchester, United Kingdom, M20 4GJ
Not Yet Recruiting
Research Team
J
Jacki Dillingham
CONTACT
L
Lissa Nazal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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