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 (NCT06318273)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (6 items).
Location: City of Hope /ID# 262059 — Duarte, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
- History of other active malignancy, as laid out in the protocol.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on screening chest CT scan.
- History of or active idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- History of or active clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (26 Sites)
- City of Hope /ID# 262059 — Duarte, California
- Univ California, San Francisco /ID# 261715 — San Francisco, California
- Yale University School of Medicine /ID# 262234 — New Haven, Connecticut
- AdventHealth Orlando /ID# 261686 — Orlando, Florida
- University of Chicago Medical Center /ID# 261605 — Chicago, Illinois
- START Midwest /ID# 264295 — Grand Rapids, Michigan
- Carolina BioOncology Institute /ID# 261602 — Huntersville, North Carolina
- Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687 — Providence, Rhode Island
- NEXT Oncology /ID# 261601 — San Antonio, Texas
- Chris O'Brien Lifehouse /ID# 261731 — Camperdown, New South Wales
- Ballarat Base Hospital /ID# 264294 — Ballarat, Victoria
- St Vincent's Hospital /ID# 264293 — Fitzroy, Victoria
- Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 270890 — Montreal, Quebec
- McGill University Health Centre - Glen Site. /ID# 271275 — Montreal, Quebec
- Centre Oscar Lambret /ID# 270602 — Lille, Nord
- Centre Leon Berard /ID# 270605 — Lyon, Rhone
- Institut Gustave Roussy /ID# 270603 — Villejuif, Île-de-France Region
- The Chaim Sheba Medical Center /ID# 261772 — Ramat Gan, Tel Aviv
- Rambam Health Care Campus- Haifa /ID# 261770 — Haifa,
- Hadassah Medical Center-Hebrew University /ID# 261771 — Jerusalem,
- National Cancer Center Hospital East /ID# 261606 — Kashiwa-shi, Chiba
- Kyoto University Hospital /ID# 261861 — Kyoto, Kyoto
- National Cancer Center Hospital /ID# 261698 — Chuo-ku, Tokyo
- Hospital Universitario Vall de Hebron /ID# 270889 — Barcelona,
- Hospital Universitario HM Sanchinarro /ID# 271345 — Madrid,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.