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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Stemline Therapeutics, Inc. Industry-sponsored |
| Locations | 15 sites (Springdale, Arkansas and 14 other locations) |
| Status | Recruiting |
| Started | January 10, 2026 |
| Main results expected | December 2, 2027 |
| Study ends | June 2, 2028 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07226427 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
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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
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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
- Study coordinator: Stemline Trials
- Email: cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com
- Phone: 1-877-332-7961
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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SYS6043 plus standard chemo vs standard chemo in platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer
This study tests SYS6043 against the doctor’s choice chemotherapy in adults with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer to see which treatment works better.
-
OPB-201 therapy for recurrent endometrial and platinum-resistant ovarian cancer
A one-time treatment with a patient’s own T cells engineered to target PRAME is being tested to see if it is safe and what dose works best for adults with recurrent endometrial cancer or platinum-resistant ovarian cancer.
-
Rina-S extension study in platinum-resistant ovarian cancer in China
This study tests whether Rina-S works as well as standard chemotherapy options for people with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer in China.
-
GB-5267 for platinum-resistant ovarian, peritoneal, or fallopian tube cancer
This early-phase trial test GB-5267 in adults with platinum-resistant ovarian cancer to see if it is safe and can help shrink tumors.
-
MUC16-targeted antibody-drug HWK-016 for advanced ovarian and endometrial cancer
This will test HWK-016, an antibody-drug that targets MUC16, in adults with advanced or metastatic ovarian or endometrial cancer, including platinum-resistant ovarian cancer.
-
HWK-007, a PTK7-targeted antibody‑drug conjugate for advanced PTK7-positive ovarian, endometrial, and certain non‑squamous lung cancers
This study will try HWK-007, a PTK7-targeted antibody‑drug conjugate given every three weeks, to see if it can shrink or control advanced PTK7-positive ovarian, endometrial, or non-squamous EGFR wild-type lung cancers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.