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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-1311 in Subjects with Advanced/Metastatic Solid Tumors

    Cancer Categories
    • Gastrointestinal (GI),Genitourinary (GU),Lung
    Karmanos Trial ID
    • 2024-080
    NCT ID
    • NCT05914116
    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
    • Ira
      Winer, M.D., Ph.D., FACOG

      Oncology - Gynecologic, Oncology - Surgical View Profile

    Objective:

    Phase 1 (Dose Escalation)

    Primary Objectives:

    • To evaluate the safety and tolerability of DB-1311.
    • To determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of DB-1311.

    Secondary Objectives:

    • To assess the preliminary antitumor activity of DB-1311.
    • To characterize the Pharmacokinetics (PK) of DB-1311 (DB-1311 antibodydrug conjugate [ADC], total anti- B7-H3 antibody, unconjugated payload P1021).
    • To assess the immunogenicity of DB1311 in targeted subjects.

    Phase 2a (Dose Expansion)

    Primary Objectives:

    • To assess the safety and tolerability of DB-1311 as monotherapy in targeted subject populations.
    • To assess the effectiveness of DB-1311 as monotherapy by assessment of objective response rate (ORR) by investigator.

    Secondary Objectives:

    • To further assess the PK of DB-1311 (DB-1311 ADC, total anti-B7-H3 antibody, unconjugated payload P1021).
    • To evaluate the prevalence and incidence of anti-drug antibody (ADA) against DB1311 in serum via a validated assay.
    • To evaluate the preliminary efficacy of DB-1311 with additional efficacy parameters.
  • 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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