Actively Recruiting
A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer
Led by Stemline Therapeutics, Inc. · Updated on 2026-05-26
100
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human, open-label clinical trial to study MEN2501, a KIF18A inhibitor, as a monotherapy in adult women with platinum-resistant ovarian cancer. The study aims to evaluate the safety, tolerability, how the body processes and responds to MEN2501, and its antitumor activity in this population. This trial is sponsored by Stemline Therapeutics, Inc. and is designed as a Phase 1 dose-escalation and dose-optimization study. Participants will receive MEN2501 as an oral tablet. The study is divided into two parts: Part A focuses on escalating the dose to find dose-limiting toxicities over a 28-day cycle, while Part B involves dose expansion and optimization to determine the recommended Phase 2 dose over approximately six months. Both parts involve treatment with MEN2501, without placebo, and the trial is randomized but open-label. Throughout the study, participants will be monitored for dose-limiting toxicities, treatment-emergent adverse events, tumor response, progression-free survival, overall survival, and pharmacokinetic measures such as plasma concentration of MEN2501. Evaluations will include safety and antitumor activity assessments over periods ranging from several months up to a year. Participation involves regular visits and assessments to track these outcomes and monitor health status.
CONDITIONS
Brief Title
A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Participants must be female.
- Participants must be 18 years of age or older.
You will not qualify if you...
- Participants with primary platinum-refractory disease.
- Other protocol-defined inclusion/exclusion criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 6 months
Participants receive the study drug MEN2501 as an oral tablet to treat platinum-resistant ovarian cancer.
Repeated 28-day cycles
Trial Site Locations
Total: 6 locations
1
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
2
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
3
Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States, 34232
Actively Recruiting
4
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Stemline Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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