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  • A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, in Participants with Ovarian Cancer

    Cancer Categories
    • Gynecologic
    Karmanos Trial ID
    • 2025-088
    NCT ID
    • NCT07226427
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I
    Principal Investigator
    • Image of Ira Winer , M.D., Ph.D., FACOG
      Ira
      Winer, M.D., Ph.D., FACOG
      Oncology - Gynecologic, Oncology - Surgical View Profile

    Objective:

    Primary Objectives:

    • Part A: To identify the maximum tolerated dose (MTD)/ maximum administrated dose (MAD) and recommended expansion doses for MEN2501 in platinum-resistant ovarian cancer
    • Part B: Establish the recommended phase 2 dose (RP2D) of MEN2501

    Secondary Objectives:

    • Evaluate the safety and tolerability of MEN2501
    • To evaluate preliminary antitumor activity of MEN2501.
    • Characterize the PK profile of MEN2501 in plasma and urine and evaluate the effect of food on the PK when administered
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    Karmanos Cancer Institute - Detroit Headquarters

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    Detroit, MI 48201
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    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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