Epithelial Ovarian Cancer Clinical Trial
Official title:
A Phase 1/1b Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Defactinib in Combination With Avelumab in Epithelial Ovarian Cancer
This is a Phase 1/1b, open-label, multicenter, dose-escalation and dose expansion trial to evaluate the safety, efficacy, PK and PD of defactinib (VS-6063) in combination with avelumab in epithelial ovarian cancer.
The study is comprised of 2 sequential parts: Part A (Dose Escalation of VS-6063) and Part B
(Expansion).
In Part A (Dose Escalation), approximately 18 subjects will receive avelumab IV treatment in
28-day cycles (10 mg/kg over approximately 1 hour on Days 1 and 15) and oral defactinib
twice-daily (BID) continuously starting on Day 1 of Cycle 1. Subject enrollment will proceed
according to a standard 3+3 design. In the absence of dose-limiting toxicity (DLT), each
subject will receive the study drug regimen for a minimum of 28 days (Cycle 1) and may
continue to receive additional cycles of study treatment until disease progression has been
documented or unacceptable toxicity or other treatment discontinuation criteria have been
met. All subjects in a cohort must have completed at least 1 cycle of dosing before dose
escalation involving new subjects entered into the next dose cohort can occur. Based on the
safety and PK data obtained in the dose escalation portion of the study, the RP2D of the
combination will be determined.
In Part B (Expansion), approximately 80 subjects will be enrolled and will receive avelumab
IV treatment in 28-day cycles (10 mg/kg over approximately 1 hour on Days 1 and 15) and oral
defactinib at the RP2D dose continuously starting on Day 1 of Cycle 1.
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