A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

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.