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  • An Open-label, Multicenter, Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Efficacy of BA3182, a Bispecific Epithelial Cell Adhesion Molecule (EpCAM)/CD3 Antibody, in Patients with Advanced Adenocarcinoma

    Cancer Categories
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Lung
    Karmanos Trial ID
    • 2023-052
    NCT ID
    • NCT05808634
    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 Tarik Hadid , M.D., MPH, MS, FACP
      Tarik
      Hadid, M.D., MPH, MS, FACP
      Oncology - Medical View Profile

    Objective:

    Part 1

    Primary Objective:

    • To define the safety profile, including dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or pharmacologically active dose (PAD) and other safety parameters for BA3182 in patients with advanced adenocarcinoma

    Secondary Objectives:

    • To evaluate the preliminary antitumor activity of BA3182
    • To characterize the pharmacokinetics (PK) of BA3182
    • To evaluate the immunogenicity of BA3182

    Part 2

    Primary Objective:

    • To assess antitumor activity of BA3182 in patients with adenocarcinoma expressing EpCAM
    • To assess the safety of BA3182 evaluating the totality of the safety data
    • To determine the recommended Phase 2 dose (RP2D)

    Secondary Objectives:

    • To further assess antitumor activity of BA3182
    • To assess the PK of BA3182
    • To evaluate the immunogenicity of BA3182
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    Locations

    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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