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

Jan 10, 2026

Study Type

INTERVENTIONAL

Conditions

Platinum Resistant Ovarian Cancer

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

Plain Language Summary

Simplified for easier understanding

This is the first study in humans testing a new drug called MEN2501 in people with platinum-resistant ovarian cancer (ovarian cancer that has stopped responding to platinum-based chemotherapy). The study aims to evaluate the drug's safety and find the right dose. **You may be eligible if...** - You have been confirmed to have high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer - Your cancer is platinum-resistant (meaning it stopped responding to platinum-based chemotherapy) **You may NOT be eligible if...** - Your cancer never responded to platinum-based chemotherapy from the very beginning (called primary platinum-refractory disease) - Other protocol-specific criteria may also apply Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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