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

Other illness

• History and/or current evidence of clinically significant retinal disorder
• A serious illness or medical condition(s)

Lab values

• History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.

Other

• History and/or current evidence of clinically significant ectopic mineralization/calcification.
• Pregnant or breast-feeding female

• 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.