NCT07226427

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
25mo left

Started Nov 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Nov 2025Jun 2028

Study Start

First participant enrolled

November 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2028

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

November 6, 2025

Last Update Submit

November 6, 2025

Conditions

Platinum-resistant Ovarian Cancer

Keywords

MEN2501First-in-HumanOvarian Cancer

Outcome Measures

Primary Outcomes (2)

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

    Cycle 1 (28 days/cycle)

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

    Up to approximately 6 months

Secondary Outcomes (8)

  • Number of Participants with Treatment-emergent Adverse Events

    Up to approximately 7 months

  • Overall Response Rate

    Up to approximately 7 months

  • Duration of Objective Response

    Up to approximately 7 months

  • Clinical Benefit Rate

    Up to approximately 7 months

  • Progression-free Survival

    Up to approximately 12 months

  • +3 more secondary outcomes

Study Arms (2)

Part A: MEN2501 Dose Escalation

EXPERIMENTAL
Drug: MEN2501

Part B: MEN2501 Dose Expansion & Optimization

EXPERIMENTAL
Drug: MEN2501

Interventions

MEN2501DRUG

Oral tablet

Part A: MEN2501 Dose EscalationPart B: MEN2501 Dose Expansion & Optimization

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

You may not qualify if:

  • Participants with primary platinum-refractory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Medical Director

    Stemline Therapeutics, Inc.

    STUDY DIRECTOR

Central Study Contacts

Stemline Trials

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Participants enrolled in the Part B dose expansion will be randomized between expansion doses.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2025

First Posted

November 10, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

December 2, 2027

Study Completion (Estimated)

June 2, 2028

Last Updated

November 10, 2025

Record last verified: 2025-11

Locations

US(1)