A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Sponsor: Elevar Therapeutics
ClinicalTrials ID:NCT07359820
This trial assesses the efficacy and safety of lirafugratinib, an oral FGFR2 inhibitor, in adults with unresectable, locally advanced, or metastatic solid tumors with FGFR2 fusion/rearrangement. Eligible participants must have measurable disease, ECOG status 0-1, and prior systemic therapy, excluding FGFR inhibitors. Participants will take lirafugratinib and attend regular clinic visits.
Patient Parameters
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Program Overview
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 Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic | 85054 | Phoenix | Arizona |
| Mayo Clinic | 32224 | Jacksonville | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Chicago Medical Center | 60637 | Chicago | Illinois |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| The University of Texas M.D. Anderson Cancer Center | 77030 | Houston | Texas |
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