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

Purpose

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.

Condition

  • Platinum-resistant Ovarian Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Participants enrolled in the Part B dose expansion will be randomized between expansion doses.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: MEN2501 Dose Escalation
  • Drug: MEN2501
    Oral tablet
Experimental
Part B: MEN2501 Dose Expansion & Optimization
  • Drug: MEN2501
    Oral tablet

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Stemline Therapeutics, Inc.

Study Contact

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