Clinical Trial

A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Active, Not Recruiting Phase 2
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Summary
This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with metastatic Castration Resistant Prostate Cancer (mCRPC) with prior exposure to at least 1 Androgen Receptor Pathway Inhibitor (ARPI) and 0-2 taxane regimens and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and pharmacokinetic (PK) data from participants randomized in the study will be evaluated.
Protocol Amendment History 4 changes
notable Primary completion moved earlier: 2028-01-07 -> 2027-07-16 2026-04-22
minor Completion moved earlier: 2028-11-04 -> 2028-05-14 2026-04-22
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-09
notable Trial sites reduced: 50 -> 47 locations 2026-04-09
Trial Details
NCT Number NCT07047118
Lead Sponsor Novartis Pharmaceuticals
Conditions Prostatic Cancer, Castration-Resistant
Enrollment 138 participants
Start Date 2025-07-03
Primary Completion 2027-07-16 (estimated)
Study Completion 2028-05-14 (estimated)
Updated on ClinicalTrials.gov 2026-07-09