Clinical trial Recruiting at 15 sites Phase 1 Interventional Ages 18 and up Women only

MEN2501 treatment for platinum-resistant ovarian cancer

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

Run by Stemline Therapeutics, Inc. · NCT07226427 · Data updated 2026-11-12

This trial tests a new drug called MEN2501 in adults whose ovarian cancer no longer responds to platinum chemotherapy.

More Platinum-resistant Ovarian Cancer trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment100 (estimated)
SponsorStemline Therapeutics, Inc.
Industry-sponsored
Locations15 sites (Springdale, Arkansas and 14 other locations)
StatusRecruiting
StartedJanuary 10, 2026
Main results expectedDecember 2, 2027
Study endsJune 2, 2028
Registry record updatedJuly 6, 2026
Trial IDNCT07226427 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with histologically confirmed high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer whose disease is platinum-resistant (not platinum-refractory) and who meet protocol health and laboratory criteria.

Probably not a fit

Patients with primary platinum-refractory disease, non-eligible tumor histologies, significant organ dysfunction, or inability to travel to the study site are unlikely to benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label Phase 1 study uses dose-escalation and dose-optimization to find a safe and tolerable dose of MEN2501 as a single agent for adults with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. The trial will measure safety, tolerability, pharmacokinetics, pharmacodynamics, and any signs of antitumor activity. Participants will receive escalating doses at the study site with regular safety labs, imaging, and PK/PD sampling to guide dose decisions. Cohorts may expand at recommended doses to further characterize preliminary activity and side effects.

Why it matters

Potential benefit: If MEN2501 proves safe and active, it could provide a new treatment option that shrinks tumors or slows disease progression in patients with platinum-resistant ovarian cancer.

How similar studies have gone: MEN2501 is being tested in humans for the first time, so there are no prior human data for this agent, while other experimental therapies in platinum-resistant ovarian cancer have shown mixed results.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Highlands Oncology Group
    Springdale, Arkansas, United States
    Recruiting
  • Yale University
    New Haven, Connecticut, United States
    Recruiting
  • Florida Cancer Specialists & Research Institute
    Sarasota, Florida, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Karmanos Cancer Institute
    Detroit, Michigan, United States
    Recruiting
  • Mayo Clinic
    Rochester, Minnesota, United States
    Recruiting
Show 9 more locations
  • NEXT Virginia
    Fairfax, Virginia, United States
    Recruiting
  • Icon Cancer Centre
    South Brisbane, Queensland, Australia
    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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.