A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a first-in-human, open-label, dose-escalation, dose-optimization trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of MEN2501 monotherapy in adult participants with platinum-resistant ovarian cancer.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Locations
United States
Virginia
NEXT Virginia
RECRUITING
Fairfax
Contact Information
Primary
Stemline Trials
cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com
1-877-332-7961
Time Frame
Start Date: 2025-11
Estimated Completion Date: 2028-06-02
Participants
Target number of participants: 100
Treatments
Experimental: Part A: MEN2501 Dose Escalation
Experimental: Part B: MEN2501 Dose Expansion & Optimization
Related Therapeutic Areas
Sponsors
Leads: Stemline Therapeutics, Inc.