A Phase I, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer

Study Identifier:
MEN2501-01
CT.gov Identifier:
NCT07226427
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Ovarian
Fallopian Tube
Primary Peritoneal
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part A: MEN2501 Dose Escalation
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Drug: Drug: MEN2501
Drug: Oral tablet
Drug: EXPERIMENTAL: Part B: MEN2501 Dose Expansion & Optimization
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Ramon Yarza
Status
Will Be Recruiting
Condition(s) Treated at Site
Ovarian
Fallopian Tube
Primary Peritoneal