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  • A First-In-Human, Phase 1, Dose-Escalation Study of SGR-3515 In Participants with Advanced Solid Tumors

    Cancer Categories
    • Lung
    Karmanos Trial ID
    • 2024-098
    NCT ID
    • NCT06463340
    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:

    • Evaluate SGR-3515 safety, tolerability, dose-limiting toxicities (DLTs) in participants with advanced solid tumors
    • Identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) and recommended schedule (RP2S) of SGR-3515

    Secondary Objectives:

    • Evaluate SGR-3515 PK in participants with advanced solid tumors
    • Evaluate SGR-3515 preliminary anti-tumor activity in participants with advanced solid tumors as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or the applicable disease specific criteria
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    Karmanos Cancer Institute - Detroit Headquarters

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    Detroit, MI 48201
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