A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer (NCT05067140)
A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 Monotherapy and in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
This first-in-human, Phase 1/2, open-label study evaluates the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of JSB462 (luxdegalutamide, previously ARV-766) administered as monotherapy and in combination with abiraterone in participants with metastatic prostate cancer. The study includes dose-escalation and cohort expansion components to determine the recommended Phase 2 dose and assess clinical activity.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical — 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 (17 Sites)
- City of Hope National Medical — Duarte, California
- University of California San Diego - Moores Cancer Center — La Jolla, California
- Providence Saint Johns Health Ctr — Santa Monica, California
- Yale Cancer Center — New Haven, Connecticut
- Florida Cancer Specialists — Fort Myers, Florida
- Chesapeake Urology Associates — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Karmanos Cancer Institute — Detroit, Michigan
- Roswell Park Cancer Institute — Buffalo, New York
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- Univ of Pittsburgh Cancer Inst — Pittsburgh, Pennsylvania
- Carolina Urologic Research Center — Myrtle Beach, South Carolina
- SCRI Oncology Partners — Nashville, Tennessee
- Urology San Antonio — San Antonio, Texas
- University of Virginia Medical Center — Charlottesville, Virginia
- Virginia Cancer Specialists — Fairfax, Virginia
- University of Wisconsin Paul P Carbone Comp Cancer Center — Madison, Wisconsin
📞 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 Prostate Cancer Metastatic
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- Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer — Duarte, California
- Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer — Victoria, British Columbia
- Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer — Baltimore, Maryland
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Explore by condition: All Prostate Cancer Metastatic 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.