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

NCT07226427 · tracked via the Priya Life Science USA tracker

Sponsor

Stemline Therapeutics, Inc.

Phase

Phase 1

Started

2026-01-10

Last updated

2026-07-06

Condition(s) studied

Platinum-resistant Ovarian Cancer

Investigational drug(s) / intervention(s)

MEN2501

MEN2501: Oral tablet

Study 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

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs) — Cycle 1 (28 days/cycle)
Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501 — Up to approximately 6 months

Trial sites (15)

Facility	City	Region	Status
Highlands Oncology Group	Springdale	Arkansas	Recruiting
Yale University	New Haven	Connecticut	Recruiting
Florida Cancer Specialists & Research Institute	Sarasota	Florida	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
NEXT Virginia	Fairfax	Virginia	Recruiting
Icon Cancer Centre	South Brisbane	Queensland	Recruiting
Cancer Research SA	Aberfoyle Park	Australia	Recruiting
Hospital Universitario Dexeus - Grupo Quironsalud	Barcelona	Spain	Recruiting
Clínica Universidad Navarra	Madrid	Spain	Recruiting
Hospital Universitario 12 de Octubre	Madrid	Spain	Recruiting
Hospital Universitario HM Sanchinarro	Madrid	Spain	Recruiting
Clínica Universidad de Navarra	Pamplona	Spain	Recruiting
Hospital Quironsalud Madrid	Pozuelo de Alarcón	Spain	Recruiting

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A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer Recruiting

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Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07226427 on ClinicalTrials.gov ↗ ← All trials in the USA