Study of FP-1039 in Subjects With Endometrial Cancers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-Label Phase 2 Pilot Study Evaluating the Activity and Safety of FP 1039 in Subjects With Advanced and/or Recurrent Endometrial Cancers With Specific FGFR2 Mutations

Conditions
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Endometrial Cancers With FGFR2 Mutations

Intervention / Treatment
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* Drug: FP-1039


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for study participation: Evidence of histologically or cytologically proven metastatic or locally advanced unresectable endometrial cancer bearing either the S252W or the P243R FGFR2 mutation. Female at least 18 years of age Performance status ≤ 1 on the ECOG Performance Status Scale Adequate cardiac function e.g., NYHA Class I or II Estimated life expectancy of at least 16 weeks Measurable or evaluable disease by physical or radiologic examination Must have recovered from the adverse effects of prior therapy at the time of enrollment to ≤ Grade 1 (excluding alopecia) Meets laboratory criteria as specified per protocol. Exclusion Criteria for study participation: Prior treatment with an inhibitor of the FGF/FGFR pathway Prior treatment with any of the following: Cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (antibodies, immune modulators, cytokines) within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks prior to the scheduled first dose of FP-1039 A small-molecule kinase inhibitor (including investigational small-molecule kinase inhibitors) within 14 days (or 5 half lives of the drug or active metabolites) of the scheduled first dose of FP-1039 Any other investigational therapy within 28 days of the first scheduled dose of FP-1039 Note: Any eligibility questions related to prior therapies including the timing from prior therapies should be discussed and a decision agreed on by the Investigator and the Sponsor in writing prior to the subject entering the study Known hypersensitivity to the components of FP-1039 Current anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1mg/day is permitted) PT/INR and/or PTT test results at screening that are above 1.3 x the laboratory ULN. No exclusionary medical history as described per the protocol. Presence of any of the following conditions: Luminal intestinal cancers and/or abdominal carcinomatosis History of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment Other potential risk factors for gastrointestinal perforation (i.e., acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction) History of organ, bone marrow, or stem cell transplantation Pregnant or breast feeding Clinically apparent CNS metastases or carcinomatous meningitis Note: Subjects with CNS metastases who have completed a course of radiotherapy and who have been on a stable dose of glucocorticoids for at least 4 weeks are eligible. Uncontrolled intercurrent illness including but not limited to an active infection, hypertension, psychiatric, or substance abuse disorders that would preclude consent, limit compliance with study requirements, or confound safety interpretation. Unable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FP-1039<br>FP-1039 | Drug: FP-1039<br>* FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations | up to 1 year | 
| Progression-free survival | To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer | up to 1 year | 
| Pharmacokinetics of Plasma | To determine pharmacokinetics (PK) plasma concentration at specified times | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial cancer, FGFR2 mutations