A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer

Study Identifier
M24-742
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2024-516772-15-00
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Study Details

Medical Condition
  • Prostate Cancer
  • Study Drug
  • ABBV-969
  • Phase
    Phase 1
    Sex
    Male
    Age
    18+ years

    Protocol Summary

    Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy.

    ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 230 adult participants will be enrolled in the study across sites worldwide.

    In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

    Study Locations

    Location
    Status
    Location
    City of Hope /ID# 262059
    Duarte, California, United States, 91010
    Status
    Recruiting
    Location
    Univ California, San Francisco /ID# 261715
    San Francisco, California, United States, 94143-2204
    Status
    Recruiting
    Location
    Yale University School of Medicine /ID# 262234
    New Haven, Connecticut, United States, 06510
    Status
    Recruiting
    Location
    AdventHealth Orlando /ID# 261686
    Orlando, Florida, United States, 32803
    Status
    Recruiting
    Location
    University of Chicago Medical Center /ID# 261605
    Chicago, Illinois, United States, 60637
    Status
    Recruiting
    Location
    START Midwest /ID# 264295
    Grand Rapids, Michigan, United States, 49546
    Status
    Recruiting
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