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

NCT ID: NCT07226427

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Platinum-resistant Ovarian Cancer

Keywords

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MEN2501 First-in-Human Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Participants enrolled in the Part B dose expansion will be randomized between expansion doses.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: MEN2501 Dose Escalation

Group Type EXPERIMENTAL

MEN2501

Intervention Type DRUG

Oral tablet

Part B: MEN2501 Dose Expansion & Optimization

Group Type EXPERIMENTAL

MEN2501

Intervention Type DRUG

Oral tablet

Interventions

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MEN2501

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Participants with primary platinum-refractory disease.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Stemline Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Stemline Therapeutics, Inc.

Locations

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NEXT Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stemline Trials

Role: CONTACT

Phone: 1-877-332-7961

Email: [email protected]; [email protected]

Other Identifiers

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MEN2501-01

Identifier Type: -

Identifier Source: org_study_id