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  • A Phase 1, First-in-Human Study of DS-9606a in Patients with Tumor Types Known to Express Claudin-6 (CLDN6)

    Cancer Categories
    • Gastrointestinal (GI),Gynecologic,Lung
    Karmanos Trial ID
    • 2022-055
    NCT ID
    • NCT05394675
    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
    • Mohammed Najeeb
      Al Hallak, M.D., MS

      Oncology - Medical View Profile

    Objective:

    Primary Objectives:

    • Dose Escalation (Part A): Investigate the safety and tolerability of DS-9606a and determine the maximumtolerated dose (MTD) and the recommended doses for expansion (RDE/RDEs)
    • Dose Expansion (Part B): Further evaluate the safety and tolerability of DS-9606a, and investigate the overall response rate (ORR) of DS-9606a, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) per the Investigator at the RDE/RDEs.

    Secondary Objectives:

    • Characterize the pharmacokinetic (PK) properties of DS-9606a, total anti-CLDN6 antibody, and the unconjugated pyrrolobenzodiazepine (PBD) payload
    • Investigate the duration of response (DoR) and progression free survival (PFS) of DS-9606a, according to RECIST v1.1 per the Investigator
    • Assess the immunogenicity of DS-9606a
  • 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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