A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
ARV-766: Parts A and C: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment. Part B: 100mg or 300mg oral tablet(s) once daily in 28 day cycles.
Abiraterone: Abiraterone is administered orally in combination with ARV-766, typically on an empty stomach with water, in accordance with prescribing information and standard clinical practice.
Corticosteroid (e.g., prednisone/prednisolone): Prednisone or prednisolone was administered in accordance with local prescribing information during treatment with abiraterone acetate.
Androgen Deprivation Therapy (ADT): Ongoing androgen deprivation therapy, including luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or prior orchiectomy, is maintained per investigator choice or patient preference.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Part A: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment — Up to 28 days
Number and proportion of participants experiencing dose-limiting toxicities during the DLT evaluation period to assess safety and determine the maximum tolerated dose (MTD) of ARV-766 and/or recommended Phase 2 dose (RP2D) - Part C: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment — Up to 28 Days
Number and proportion of participants experiencing dose-limiting toxicities during the DLT evaluation period to determine the recommended dose of ARV-766 in combination with abiraterone - Parts A and C: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) — From first dose through approximately 30 days after last dose
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug. - Parts A and C: Incidence of laboratory abnormalities — From first dose through approximately 30 days after last dose
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing. - Part B: Prostate-Specific Antigen 30% Response Rate (PSA30) — 12 Weeks
Prostate Specific Antigen 30 (PSA30) Rate is defined as the proportion of participants who achieve a ≥30% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between - Part B: Prostate-Specific Antigen 50% Response Rate (PSA50) — 12 Weeks
Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05067140 on ClinicalTrials.gov ↗ ← All trials in the USA