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  • A Study of PARG Inhibitor IDE161 in Participants with Advanced Solid Tumors

    Cancer Categories
    • Breast,Gynecologic
    Karmanos Trial ID
    • 2023-080
    NCT ID
    • NCT05787587
    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

    Objective:

    Primary Objectives:

    • Part 1 (Dose Escalation): To characterize the
      safety and tolerability of IDE161 monotherapy to
      determine the MTD/MAD, and/or RDE
    • Part 2 (Dose Expansion): To further assess the
      safety and tolerability of IDE161 monotherapy at
      the RDE
    • Part 2: To evaluate preliminary anti-tumor
      activity of IDE161 monotherapy

    Secondary Objectives:

    • Part 1: To evaluate preliminary anti-tumor
      activity of IDE161 monotherapy
    • Part 2: Assess risk/benefit at an IDE161
      monotherapy dose and exposure alternative to
      the initial expansion dose
    • Both parts: To characterize the single and
      multiple dose PK of IDE161 monotherapy
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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

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    Farmington Hills, MI 48334
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