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NCT Number: NCT07226427

A First-in-Human Study of MEN2501 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.

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Key information

Conditions

Platinum-resistant Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Icon Cancer Centre, South Brisbane, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MEN2501

Drug

Oral tablet

Primary outcomes

  1. Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs)

    Time frame: Cycle 1 (28 days/cycle)

  2. Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501

    Time frame: Up to approximately 6 months

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events

    Time frame: Up to approximately 7 months

  2. Overall Response Rate

    Time frame: Up to approximately 7 months

  3. Duration of Objective Response

    Time frame: Up to approximately 7 months

  4. Clinical Benefit Rate

    Time frame: Up to approximately 7 months

  5. Progression-free Survival

    Time frame: Up to approximately 12 months

  6. Overall Survival

    Time frame: Up to approximately 12 months

  7. Time To Response

    Time frame: Up to approximately 7 months

  8. Area Under the Plasma Concentration-time Curve (AUC) of MEN2501

    Time frame: Up to approximately 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Stemline Trials

CONTACT

[email protected]; [email protected]

1-877-332-7961

Sponsors and collaborators

Lead sponsor

Stemline Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 10, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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