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  • A Phase 1 Study of FOR46 Administered Every 21 Days in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • 2018-163
    NCT ID
    • NCT03575819
    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
    Principal Investigator


    Primary Objective(s):
    • Dose-Escalation Period
      • Evaluate the safety and tolerability of FOR46 administered as an intravenous (IV) infusion
      • Determine the maximum-tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of FOR46 in patients with mCRPC
    • Dose-Expansion Period
      • Continue to characterize the safety profile of FOR46 at the dose level selected for the dose-expansion period
      • Evaluate the antitumor activity of FOR46 in 2 cohorts of mCRPC patients whose disease has progressed on androgen-signaling inhibitors (ASIs):
      • Cohort 1: Patients with prostate carcinoma without histologic evidence of small-cell/neuroendocrine carcinoma
      • Cohort 2: Patients with unequivocal histologic evidence of small-cell/neuroendocrine prostate carcinoma. For this cohort, patients may have pure small-cell/neuroendocrine carcinoma or a mix of small-cell/neuroendocrine and adenocarcinoma
    Secondary Objective(s):
    • Dose-Escalation and Dose-Expansion Periods
      • Characterize the pharmacokinetics (PK) of FOR46 and components (YS5FL total antibody and MMAE)
      • Characterize the immunogenicity of FOR46
    • Dose-Escalation Period
      • Determine antitumor activity of FOR46 in patients with mCRPC
    • Dose-Expansion Period
      • Determine other indicators of antitumor activity
    Exploratory Objective(s):
    • Evaluate possible relationships between CD46 expression in tumor samples and various parameters indicative of antitumor activity
    • Evaluate the effect of FOR46 treatment on modulation of immune parameters
    • Evaluate the effect of FOR46 treatment on modulation of androgen receptor (AR) expression and signaling
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