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)
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
🩺 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: Review the eligibility criteria below.
Location: City of Hope /ID# 262059 — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 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,
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Metastatic Castration-Resistant Prostate Cancer
- A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer — San Francisco, California
- Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment — Tucson, Arizona
- ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC — Sacramento, California
- FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) — Duarte, California
- FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer — San Francisco, California
Explore by condition: All Metastatic Castration-Resistant Prostate Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.