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, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in second line and CUE-101 Combination Therapy with Pembrolizumab in first line Patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

    Cancer Categories
    • Gastrointestinal (GI),Head and Neck
    Karmanos Trial ID
    • 2019-087
    NCT ID
    • NCT03978689
    Age Group
    • Adult
    • 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


    Primary Objective(s):
    • Assess the safety and tolerability of CUE-101 in subjects with recurrent/metastatic HPV16-driven malignancies (HLA-A*0201, HPV16+ disease: HPV 16 genotyping, plus tumor p16+) and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) based on markers of biological activity (biologically effective dose) (Part A)
    • Evaluate the PK of CUE-101 when administered in subjects with recurrent/metastatic HPV16-driven malignancies (Parts A and B)
    Secondary Objective(s):
    • Confirm safety and evaluate antitumor activity at the RP2D (Part B)
    • Assess the preliminary antitumor activity of CUE-101 based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Parts A and B)
    • Assess the potential for immune response upon treatment with CUE-101 (Parts A and B)
    • Assess the potential immunogenicity of CUE-101 (Parts A and B)

    The Exploratory Objectives of this study are to assess blood and tissue-based biomarkers of activity and immune effects (Parts A and B)
  • 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