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 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients with Metastatic Castration-Resistant Prostate Cancer

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • 2022-104
    NCT ID
    • NCT05067140
    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


    Primary Objectives:

    Part A – Phase 1 Dose Escalation

    • To evaluate the safety and tolerability of ARV-766 in
      successive cohorts of participants with prostate cancer
      to estimate the maximum tolerated dose (MTD) or
      maximum administered dose and select the potential
      recommended Phase 2 dose/schedule (RP2D).

    Part B – Phase 2 Cohort Expansion

    • To evaluate the clinical antitumor activity of ARV-766
      in participants with mCRPC in RP2D dose cohort(s)

    Seconday Objectives:

    Part A – Phase 1 Dose Escalation

    • To characterize the pharmacokinetics (PK) of ARV766, ARV-767 or combined ARV-766 and ARV-767
      following single and multiple dosing.
    • To explore the antitumor activity in the study
      population and relevant molecularly defined subsets of

    Part B – Phase 2 Cohort Expansion

    • To evaluate additional efficacy endpoints in RP2D dose
    • To evaluate additional safety endpoints in RP2D dose
  • 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