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  • A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects with Advanced/Metastatic Solid Tumors

    Cancer Categories
    • Breast,Gastrointestinal (GI),Lung
    Karmanos Trial ID
    • 2022-100
    NCT ID
    • NCT05438329
    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
    • Hirva
      Mamdani, M.D.

      Lung Cancer Screening, Oncology - Medical View Profile

    Objective:

    Phase 1 (Dose Escalation)

    Primary Objectives:

    • To evaluate the safety and tolerability of DB-1305 in subjects with advanced solid tumors.
    • To determine the MTD and/or the RP2D of DB-1305.

    Secondary Objectives:

    • To assess the preliminary antitumor activity of DB-1305.
    • To characterize the Pharmacokinetics (PK) of DB-1305 (DB-1305 antibodydrug conjugate [ADC], total anti- Trop-2 antibody, unconjugated payload P1021).
    • To assess the immunogenicity of DB-1305 in targeted subjects.

    Phase 2a (Dose Expansion)

    Primary Objectives:

    • To assess the safety and tolerability of DB-1305 in targeted subject populations.
    • To assess the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for DB1305 in subjects with select advanced solid tumors

    Secondary Objectives:

    • To further assess the PK of DB-1305 (DB-1305 ADC, total anti-Trop2 antibody, unconjugated payload P1021.
    • To evaluate the prevalence of anti-drug antibody (ADA) against DB-1305 in serum via a validated assay.
    • To evaluate the preliminary efficacy of DB-1305 with additional efficacy parameters.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266