A Phase II randomized open-label multi-center study of JSB462 (luxdegalutamide) in combination with abiraterone in adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC)

Brief description of study

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 QD doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with 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.


Clinical Study Identifier: s25-00830
ClinicalTrials.gov Identifier: NCT06991556
Principal Investigator: Andrew Laccetti.
Other Investigators: Emily Davidson, Victor Ricardo Adorno Febles, Minas Platon Economides, Casey E Chambers, Stephanie M Erichsen, Mary K O'Keeffe, Justin Lebenthal, David R. Wise.


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