A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer
Status and phase
Enrolling
Phase 1
Conditions
Platinum-resistant Ovarian Cancer
Treatments
Drug: MEN2501
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)
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
Trial contacts and locations
1
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Central trial contact
Stemline Trials
Data sourced from clinicaltrials.gov
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