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A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Trial Status: active
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.
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.
