A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer

Stemline Therapeutics, Inc.

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

Age range: 18+ years
Sex: Female
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Key Exclusion Criteria: * Participants with primary platinum-refractory disease. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Interventions

Drug
MEN2501
Oral tablet

Location

NEXT Virginia
Fairfax, Virginia