Michael J. Goodheart
This Phase 1, open-label study will evaluate VT-101, an investigational small-molecule therapy, in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. The primary objectives are to assess the safety, tolerability, and pharmacokinetic profile of VT-101 and to identify a recommended dose for further study. Secondary and exploratory objectives include evaluation of preliminary antitumor activity and characterization of treatment-related effects in participants with limited standard treatment options.
This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. Eligible participants must have disease that has progressed following prior therapy or have exhausted, refused, become intolerant of, or are otherwise ineligible for available standard treatment options. Participants will receive VT-101 administered according to a dose-escalation design to evaluate the safety profile of escalating dose levels and to…
ELIGIBILITY CRITERIA Inclusion Criteria: * Female participant * Age ≥ 18 years * Histologically confirmed advanced, recurrent, or relapsed epithelial ovarian cancer * Has received prior standard therapy for ovarian cancer, OR has refused standard therapy, OR is intolerant to standard therapy, OR is not eligible for standard therapy * ECOG Performance Status of 0, 1, or 2 * Adequate bone marrow, liver, and kidney function as defined by the protocol * Able to comply with study procedures and provide informed consent * For women of childbearing potential: agrees to use protocol-required contrac…
VT-101 is an investigational therapy consisting of autologous M1 macrophage-derived vesicles generated through membrane fragmentation. VT-101 is administered intraperitoneally via an implanted port over approximately 45 minutes, once weekly on Days 1, 8, 15, and 22, for four doses. Phase I dose escalation follows a standard 3+3 design, beginning at 1 × 10⁸ vesicles per dose and escalating to 1 × 10⁹ and 1 × 10¹⁰ vesicles per dose. Each participant receives the same dose level. After the maximum tolerated dose is established, an expansion cohort will evaluate preliminary efficacy at that dose.
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