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NCT05067140 · ClinicalTrials.gov record · last posted 2026-08-18

A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
Started2021-09-02
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-19
Primary endpoint(s) modified
WasPart A: Incidence of Dose Limiting Toxicities of ARV-766, Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766, Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766, Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC, Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination, Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination, Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination, Part D: To evaluate the clinical anti-tumor activity of ARV-766 / abiraterone combination in patients with NHA-naïve mPC
NowPart A: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment, Part B: Prostate-Specific Antigen 30% Response Rate (PSA30), Part B: Prostate-Specific Antigen 50% Response Rate (PSA50), Part C: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment, Parts A and C: Incidence of laboratory abnormalities, Parts A and C: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
2026-08-19
Trial arms changed: 2 → 3
2026-08-19
Trial sites reduced: 23 → 17 locations
Trial Details
NCT Number NCT05067140
Lead Sponsor Novartis Pharmaceuticals
Conditions Prostate Cancer Metastatic
Enrollment 164 participants
Start Date 2021-09-02
Primary Completion 2027-05-25 (estimated)
Study Completion 2027-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-18