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
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