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Phase 1 Study of VT-101 in Advanced Ovarian Cancer
Sponsor: Michael J. Goodheart
Summary
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.
Official title: A Phase 1 Dose-Finding, Safety, and Preliminary Clinical Activity Study of VT-101 in Advanced Ovarian Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2026-10-23
Completion Date
2030-10-23
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
VT-101
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.