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 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

    Cancer Categories
    • Breast,Gastrointestinal (GI),Gynecologic,Lung
    Karmanos Trial ID
    • 2020-121
    NCT ID
    • NCT04691375
    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
    • Ira
      Winer, M.D., Ph.D., FACOG

      Oncology - Gynecologic, Oncology - Surgical 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