There is one clinical trial.
An open-label, non-randomized, single arm study to assess the safety, tolerability, and pharmacokinetics of FP-1039 given by weekly intravenous (IV) administrations in advanced endometrial cancer patients with FGFR2-specific mutations. FP-1039 will be dosed weekly starting at a dose of up to 16 mg/kg.
Evidence of histologically or cytologically proven metastatic or locally advanced unresectable endometrial cancer bearing either the S252W or the P243R FGFR2 mutation. --- S252W --- --- P243R ---
Description: To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations
Measure: Response rate Time: up to 1 yearDescription: To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations
Measure: Progression-free survival Time: 6 monthsDescription: To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer
Measure: Safety and tolerability Time: up to 1 yearDescription: To determine pharmacokinetics (PK) plasma concentration at specified times
Measure: Pharmacokinetics of Plasma Time: up to 1 year