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 Response Assessment in Neuro-Oncology 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