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