Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®22841 Monotherapy and in Combination with Pembrolizumab in Subjects with Selected Advanced Solid Tumors (DUET-4)

    Cancer Categories
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
    Karmanos Trial ID
    • 2019-026
    NCT ID
    • NCT03849469
    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

    Objective:

    Primary Objective(s):
    • To evaluate the safety/tolerability profile and the maximum tolerated dose (MTD) and/or recommended dose(RD) of XmAb22841 administered by intravenous (IV) dosing on Days 1 and 15 of each 28-day cycle insubjects with advanced solid tumors who have progressed after treatment with standard/approved therapies or for whom there are no appropriate therapies available
    • To evaluate the safety/tolerability profile and the MTD and/or RD of XmAb22841 administered by IV dosingon Days 1 and 15 of each 28-day cycle with pembrolizumab 200 mg IV every 21 days in subjects with advanced solid tumors who have either (1) progressed after treatment with standard/approved therapies or for whom there are no appropriate therapies available or (2) for whom pembrolizumab as a single agent is indicated
    Secondary Objective(s):
    • To characterize the pharmacokinetics (PK) and immunogenicity of XmAb22841 administered without and with pembrolizumab
    • To assess preliminary anti-tumor activity of XmAb22841 without and with pembrolizumab by objectiveresponse rates (ORR), best overall response rates, progression-free survival (PFS), and duration of response(DOR) per response evaluation criteria outlined in the Response Evaluation Criteria in Solid Tumors (RECIST)guideline (version 1.1)
  • 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 Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

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