Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

Inclusion Criteria

• Life expectancy of at least 3 months
• ECOG performance status of 0 to 1 • In sexually-active patients, willingness to use 2 effective methods of contraception
• Adequate hematological and organ function, confirmed by lab values
• Tumor tissue must be available for prospective determination of FGFR2b overexpression
• Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
• Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
• Measurable disease as defined by RECIST version 1.1

Exclusion Criteria

• Untreated or symptomatic central nervous system (CNS) metastases
• Impaired cardiac function or clinically significant cardiac disease
• Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
• Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
• Retinal disease or a history of retinal disease or detachment
• Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea
• Major surgical procedures are not allowed ≤28 days prior to FPA144 administration
• Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study
• Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
• Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate
• History of prior malignancy except:
• a) Curatively treated non-melanoma skin cancer or
• b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
• c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
• Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway