Clinical Trials

Key Inclusion Criteria

- Histologically or cytologically confirmed unresectable or metastatic solid tumor

- Documented FGFR2 gene fusion, mutation, or amplification 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

- Patient must have disease that is refractory to standard therapy, disease that has not
adequately responded to standard therapy, disease for which standard or curative
therapy does not exist, or the patient must be intolerant to or have declined standard
therapy

- Part 2 dose expansion patients with Cholangiocarcinoma:

- Group 1: CCA patients with an FGFR2 fusion previously treated with an FGFRi

- Group 2: CCA patients with an FGFR2 fusion with prior chemotherapy but not
previously treated with an FGFRi

- Group 6: CCA patients with an FGFR2 fusion with no prior chemotherapy and not
previously treated with an FGFRi. Prior adjuvant/neo-adjuvant treatment completed
>6 months before enrollment is acceptable. Up to 2 cycles of palliative
chemotherapy are allowed during screening

- Group 7: CCA patients with an FGFR2 mutation or amplification and not previously
treated with an FGFRi

- Part 2 dose expansion patients with other solid tumors (NOT Cholangiocarcinoma):

- Group 3: Non-CCA patients with an FGFR2 fusion and not previously treated with an
FGFRi

- Group 4: Non-CCA patients with an FGFR2 amplification and not previously treated
with an FGFRi

- Group 5: Non-CCA patients with an FGFR2 mutation and not previously treated with
an FGFRi

- Part 3 extension:

- CCA patients with an FGFR2 fusion with prior chemotherapy but not previously
treated with an FGFRi

Key Exclusion Criteria

- Ongoing, clinically significant FGFRi-induced retinal detachment or an ongoing
clinically significant corneal or retinal disorder

- 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/27/23. Questions regarding updates should be directed to the study team contact.