Clinical Trial

An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Recruiting Phase 2
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Summary
This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated
Protocol Amendment History 46 amendments
This ClinicalTrials.gov record has been amended 46 times since 2025-05-23; most recent amendment 2026-06-09.
Status change: Not Yet Recruiting → Recruiting 2025-06-17
Trial Details
NCT Number NCT06991556
Lead Sponsor Novartis Pharmaceuticals
Conditions Metastatic Hormone-sensitive Prostate Cancer
Enrollment 150 participants
Start Date 2025-07-07
Primary Completion 2032-03-29 (estimated)
Study Completion 2035-10-19 (estimated)
Updated on ClinicalTrials.gov 2026-06-10