Advanced Solid Tumors - FIVE Prime

A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Eligibility 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

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut, Midstate Medical Center