A Study of TAS-120 in Patients With Advanced Solid Tumors

Inclusion Criteria:

Provide written informed consent
Age ≥ 18 years of age
Has histologically or cytologically confirmed, locally advanced or metastatic cancer

The following specific criteria for each study portion

Phase 1 (Dose Escalation):

Patients with any type of solid tumor
Disease progression following standard therapies or intolerant to prior standard therapies

Phase 1 (Dose Expansion)

Have at least one FGF/FGFR aberration
Disease progression following standard therapies or were intolerant to prior standard therapies (including prior FGFR inhibitors).
Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or RANO criteria (2010) for brain tumors.

Patients with any of the following tumor types

Patients with intrahepatic or extrahepatic CCA harboring FGFR2 gene fusions or other FGFR2 aberrations
Patients with primary CNS tumors
Patients with advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
Patients with breast cancer or gastric cancer
Patients with other solid tumor types harboring FGFR gene fusions or activating mutations
Patients with solid tumor types and other FGF/FGFR alterations not listed above

Phase 2

Patients with iCCA and FGFR2 gene rearrangements (incl fusions)
Have been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy
Must have documentation of radiographic progression of disease
No prior FGFR inhibitor
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ function.

Exclusion Criteria:

History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.
History and/or current evidence of clinically significant ectopic mineralization/calcification.
History and/or current evidence of clinically significant retinal disorder
A serious illness or medical condition(s)
Pregnant or breast-feeding female