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  • A Phase 1/2, open label, first-in-human, dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of SAR445877 administered as monotherapy or in combination with other anticancer therapies in adults with advanced solid tumors

    Cancer Categories
    • Gastrointestinal (GI),Lung
    Karmanos Trial ID
    • 2023-001
    NCT ID
    • NCT05584670
    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/II
    Principal Investigator

    Objective:

    Primary Objectives:

    • Dose escalation: To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose(s), and the overall safety and tolerability profile of SAR445877 when administered as monotherapy or in combination
    • Dose expansion/ optimization: To determine the objective response rate (ORR) of SAR445877 administered as monotherapy or in combination at the recommended dose(s)

    Secondary Objectives:

    • Dose escalation: to assess preliminary clinical activity of SAR445877 monotherapy at the recommended dose(s)
    • Dose escalation and expansion/optimization: To characterize the pharmacokinetic (PK) profile of SAR445877 when administered as monotherapy or in combination and Cetuximab (safety run-in)
    • Dose escalation and expansion/optimization: To assess the potential immunogenicity of SAR445877
    • Dose expansion/optimization: To assess other indicators of antitumor activity
    • Dose expansion/optimization: To characterize the safety profile of SAR445877 monotherapy or in combination
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    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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