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  • A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-unresponsive NMIBC and High-Risk NMIBC Patients who are BCG Naïve or Received Incomplete BCG Treatment

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • 2023-108
    NCT ID
    • NCT04752722
    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
    • Ginsburg, Kevin


    Primary Objective (Phase 1):

    • To evaluate the safety and tolerability of escalating dose levels of EG-70 administered by intravesical instillation in patients with BCG-unresponsive NMIBC who are scheduled for, refuse, or are ineligible for radical cystectomy.

    Secondary Objectives (Phase 1):

    • To identify an RP2D.
    • To evaluate preliminary efficacy of EG-70 by 12 weeks.

    Primary Objectives (Phase 2):

    • To evaluate efficacy of EG-70 (determined by complete response [CR]) at 48 weeks in each cohort separately.
    • To evaluate the safety of the RP2D of EG-70 administered by intravesical instillation in patients with BCG-unresponsive NMIBC and patients with high-risk NMIBC who are BCG-naïve or have received incomplete BCG treatment.

    Secondary Objectives (Phase 2):

    • To evaluate disease-free survival rate in each cohort separately.
    • To evaluate CR at the efficacy analysis following each cycle and the duration of CR in each cohort separately.
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    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