A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MEN2501.
- Who it may be relevant to
- Registry conditions: Platinum-resistant Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer
Overview
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.
Interventions
- Drug MEN2501
Oral tablet
Primary outcome measures
- Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs) [Time frame: Cycle 1 (28 days/cycle)]
- Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501 [Time frame: Up to approximately 6 months]
Secondary outcome measures (8)
- Number of Participants with Treatment-emergent Adverse Events [Time frame: Up to approximately 7 months]
- Overall Response Rate [Time frame: Up to approximately 7 months]
- Duration of Objective Response [Time frame: Up to approximately 7 months]
- Clinical Benefit Rate [Time frame: Up to approximately 7 months]
- Progression-free Survival [Time frame: Up to approximately 12 months]
- Overall Survival [Time frame: Up to approximately 12 months]
- Time To Response [Time frame: Up to approximately 7 months]
- Area Under the Plasma Concentration-time Curve (AUC) of MEN2501 [Time frame: Up to approximately 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Highlands Oncology Group — Springdale
- Yale University — New Haven
- Florida Cancer Specialists & Research Institute — Sarasota
- Massachusetts General Hospital — Boston
- Karmanos Cancer Institute — Detroit
- Mayo Clinic — Rochester
- NEXT Virginia — Fairfax
Spain · 6 centers
- Hospital Universitario Dexeus - Grupo Quironsalud — Barcelona
- Clínica Universidad Navarra — Madrid
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario HM Sanchinarro — Madrid
- Clínica Universidad de Navarra — Pamplona
- Hospital Quironsalud Madrid — Pozuelo de Alarcón
Australia · 2 centers
- Icon Cancer Centre — South Brisbane
- Cancer Research SA — Aberfoyle Park
Identifiers
NCT: NCT07226427 · MEN2501-01