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

ConditionPlatinum-resistant Ovarian Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexFemale

Age18+

SponsorStemline Therapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Participants with primary platinum-refractory disease.

Trial design

Treatments tested in this trial

MEN2501

Treatment groups

100 Participants

are divided into 2 treatment groups

Locations

Arkansas

Highlands Oncology Group72762, Springdale United States

Connecticut

Yale University06519, New Haven United States

Florida

Florida Cancer Specialists & Research Institute34232, Sarasota United States

Michigan

Karmanos Cancer Institute48201, Detroit United States

Sponsors and collaborators

Stemline Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov