RecruitingPhase 1NCT07226427

A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer

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


Sponsor

Stemline Therapeutics, Inc.

Enrollment

100 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

  • Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Exclusion Criteria1

  • Participants with primary platinum-refractory disease.

Interventions

DRUGMEN2501

Oral tablet


Locations(1)

NEXT Virginia

Fairfax, Virginia, United States

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NCT07226427


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