RecruitingNCT07226427Updated Jul 6, 2026

A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer

A Phase 1 interventional study of MEN2501 in Platinum-resistant Ovarian Cancer, sponsored by Stemline Therapeutics, Inc.. Recruiting at 15 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Stemline Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

Started Jan 2026; still recruiting 8 months later.

Phase: Phase 1
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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 studied

Platinum-resistant Ovarian Cancer

Browse trials for

Ovarian Neoplasms 2,695

Keywords

MEN2501
First-in-Human
Ovarian Cancer

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Stemline Therapeutics, Inc. is the lead sponsor of 22 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Eligibility 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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Experimental
Part A: MEN2501 Dose Escalation
Drug: MEN2501
Experimental
Part B: MEN2501 Dose Expansion & Optimization
Drug: MEN2501

Interventions

DrugMEN2501
Oral tablet

What researchers measure

Primary outcomes

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

Secondary outcomes

Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to approximately 7 months
Overall Response Rate
Time frame: Up to approximately 7 months
Duration of Objective Response
Time frame: Up to approximately 7 months
Clinical Benefit Rate
Time frame: Up to approximately 7 months
Progression-free Survival
Time frame: Up to approximately 12 months
Overall Survival
Time frame: Up to approximately 12 months
Time To Response
Time frame: Up to approximately 7 months
Area Under the Plasma Concentration-time Curve (AUC) of MEN2501
Time frame: Up to approximately 6 months

Study locations

15 of 15 sites recruiting

Highlands Oncology Group
Springdale, Arkansas 72762, United States
Recruiting
Yale University
New Haven, Connecticut 06519, United States
Recruiting
Florida Cancer Specialists & Research Institute
Sarasota, Florida 34232, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201, United States
Recruiting
Mayo Clinic
Rochester, Minnesota 55905, United States
Recruiting
NEXT Virginia
Fairfax, Virginia 22031, United States
Recruiting
Icon Cancer Centre
South Brisbane, Queensland 4101, Australia
Recruiting
Cancer Research SA
Aberfoyle Park, 5000, Australia
Recruiting
Hospital Universitario Dexeus - Grupo Quironsalud
Barcelona, 08028, Spain
Recruiting
Clínica Universidad Navarra
Madrid, 28027, Spain
Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Recruiting
Clínica Universidad de Navarra
Pamplona, 31008, Spain
Recruiting
Hospital Quironsalud Madrid
Pozuelo de Alarcón, 28226, Spain
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07226427
Lead sponsor: Stemline Therapeutics, Inc.
Responsible party: Sponsor
First posted: Nov 10, 2025
Start date: Jan 10, 2026
Primary completion: Dec 2, 2027 (estimated)
Completion: Jun 2, 2028 (estimated)
Last update: Jul 6, 2026

Study contacts

Stemline Trials

Contact

cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com

1-877-332-7961

Medical Director

study director · Stemline Therapeutics, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Discussion

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