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

Stemline Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Platinum-resistant Ovarian Cancer

Treatments: Drug: MEN2501

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226427

MEN2501-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Part A: MEN2501 Dose Escalation

Experimental group

Treatment:

Drug: MEN2501

Part B: MEN2501 Dose Expansion & Optimization

Experimental group

Treatment:

Drug: MEN2501