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
  • Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2020-122
    NCT ID
    • NCT03646123
    Age Group
    • Both
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator
    • Dahlia
      Sano, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Part A - Dose Escalation (Phase 1a)

    Primary
    • To characterize the safety and tolerability of PY314 as a single agent and in combination with pembrolizumab in subjects with advanced refractory solid tumors including refractory to CPI if approved for that indication
    • To identify the maximum tolerated dose (MTD) and/or to determine the recommended dose for expansion (RDE) of PY314 administered alone and in combination with pembrolizumab for

    Part B

    Secondary
    • To characterize the pharmacokinetic (PK) profile of PY314 as a single agent and in combination with pembrolizumab
    • To describe, in subjects selected by pre-specified tumor histology, anti-tumor activity of PY314 administered alone and in combination with pembrolizumab
    • To evaluate the incidence of anti-drug antibody (ADA) formation to PY314
    Exploratory
    • To characterize the expression of TREM2 in the tumor microenvironment (TME) from archival tumor tissue.

    Part B - Dose Expansion (Phase 1b)

    Primary
    • To further define the safety and tolerability of PY314 alone and in combination with pembrolizumab over multiple treatment cycles in subjects with pre-defined tumor histologies and confirmed TREM2 expression
    Secondary
    • To further characterize the PK profile of PY314 as a single agent and in combination with pembrolizumab
    • To characterize the anti-tumor activity of PY314 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM2 expression
    • To evaluate the incidence of ADA formation to PY314
    Exploratory
    • To characterize expression of TREM2 in the TME in an archival specimen as well as tumor biopsy specimen obtained at time of study enrollment followed by an on-treatment CNB to determine pharmacodynamic endpoints.
  • 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

    Wayne State University

    6135 Woodward Avenue
    Detroit, MI 48202
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