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  • A Phase I/Ib Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients with Advanced or Recurrent Solid Tumors

    Cancer Categories
    • Gynecologic
    Karmanos Trial ID
    • 2022-063
    NCT ID
    • NCT04196257
    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/II
    Principal Investigator
    • Ira
      Winer, M.D., Ph.D., FACOG

      Oncology - Gynecologic, Oncology - Surgical View Profile


    Primary Objectives

    To determine:

    • The safety and tolerability of escalating doses of BP1001-A
    • The recommended Phase II dose (RP2D) of BP1001-A
    • The single and multiple dose, and steady state pharmacokinetics (PK) of BP1001-A
    • The activity of BP1001-A on Grb2 expression in tumor samples and circulating mononuclear cells

    Secondary Objectives

    • To determine evidence of tumor response by Response Evaluation Criteria in Solid Tumors RECIST) v1.1; Overall response rate (ORR) = Complete Response (CR) + Partial Response (PR)
    • To obtain estimates for other response parameters: duration of stable disease (SD), progression-free survival (PFS), overall survival (OS), and percentage of patients who survive progression-free for at least 6 months per RECIST v1.1
  • 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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