MEN2501 treatment for 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
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stemline Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Fairfax, Virginia) |
| Trial ID | NCT07226427 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Fairfax, Virginia
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Stemline Trials
- Email: cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com
- Phone: 1-877-332-7961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.