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.
FP-1039 will be administered intravenously over 30 minutes once a week. All enrolled subjects will be monitored for the occurrence of unacceptable toxicity. Subjects with no evidence of disease progression or unacceptable toxicity after 4 doses of FP-1039 may continue to receive weekly treatment provided there continues to be no evidence of disease progression or unacceptable toxicity. Dosing will be discontinued if a subject has evidence of disease progression. Disease will be assessed approximately every 2 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week.
Response rate
To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations
Time frame: up to 1 year
Progression-free survival
To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations
Time frame: 6 months
Safety and tolerability
To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer
Time frame: up to 1 year
Pharmacokinetics of Plasma
To determine pharmacokinetics (PK) plasma concentration at specified times
Time frame: up to 1 year
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