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

July 2, 2026 updated by: Stemline Therapeutics, Inc.

A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: MEN2501 Dose Escalation
Drug: MEN2501
Oral tablet
Experimental: Part B: MEN2501 Dose Expansion & Optimization
Drug: MEN2501
Oral tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stemline Therapeutics, Inc.

Investigators

  • Study Director: Medical Director, Stemline Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2026

Primary Completion (Estimated)

December 2, 2027

Study Completion (Estimated)

June 2, 2028

Study Registration Dates

First Submitted

November 6, 2025

First Submitted That Met QC Criteria

November 6, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEN2501-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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