NCT07226427PHASE1Recruiting

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

Stemline Therapeutics, Inc.

Start Date

1/10/2026

Completion Date

6/2/2028

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 Criteria

Age Range: 18 years to No maximum

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

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Conditions

Platinum-resistant Ovarian Cancer

Locations

Highlands Oncology Group

Springdale, Arkansas 72762

United States

Yale University

New Haven, Connecticut 06519

United States

Florida Cancer Specialists & Research Institute

Sarasota, Florida 34232

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

Icon Cancer Centre

South Brisbane, Queensland 4101

Australia

Cancer Research SA

Aberfoyle Park, 5000

Australia

Hospital Universitario Dexeus - Grupo Quironsalud

Barcelona, 08028

Spain

Clínica Universidad Navarra

Madrid, 28027

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario HM Sanchinarro

Madrid, 28050

Spain

Clínica Universidad de Navarra

Pamplona, 31008

Spain

Hospital Quironsalud Madrid

Pozuelo de Alarcón, 28226

Spain