A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
Public ClinicalTrials.gov record NCT05067140. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05067140
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 164 participants
Conditions and interventions
Conditions
Interventions
- ARV-766 Drug
- Abiraterone Drug
- Corticosteroid (e.g., prednisone/prednisolone) Drug
- Androgen Deprivation Therapy (ADT) Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2, 2021 (Actual)
- Primary completion
- May 25, 2027 (Estimated)
- Completion
- May 25, 2027 (Estimated)
- Last update posted
- Aug 18, 2026
2021 – 2027
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical | Duarte | California | 91010 | — |
| University of California San Diego - Moores Cancer Center | La Jolla | California | 92093-0658 | — |
| Providence Saint Johns Health Ctr | Santa Monica | California | 90404 | — |
| Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | — |
| Chesapeake Urology Associates | Baltimore | Maryland | 21204 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14203 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Univ of Pittsburgh Cancer Inst | Pittsburgh | Pennsylvania | 15232 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| Urology San Antonio | San Antonio | Texas | 78229 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| University of Wisconsin Paul P Carbone Comp Cancer Center | Madison | Wisconsin | 53792-6164 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05067140, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05067140 live on ClinicalTrials.gov.