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.