Recruiting
Phase 1

MEN2501

Sponsor:

Stemline Therapeutics, Inc.

Code:

NCT07226427

Conditions

Platinum-resistant Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MEN2501

Study Details

Brief 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.

Conditions

Platinum-resistant Ovarian Cancer

Study ID

NCT07226427

Start date

Jan 10, 2026

Status verified date

Jul, 2026

Completion date

Jun 2, 2028

Anticipated

Primary completion date

Dec 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: MEN2501 Dose Escalation

experimental: Part B: MEN2501 Dose Expansion & Optimization

Interventions

MEN2501

Oral tablet

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Stemline Trials

1-877-332-7961cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com

Locations

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Florida Cancer Specialists & Research Institute

Recruiting

Sarasota, Florida, United States, 34232

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Stemline Therapeutics, Inc.

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • MEN2501
  • First-in-Human
  • Ovarian Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stemline Therapeutics, Inc. on 2026-07-06.