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

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

Trial Details

NCT ID

NCT06991556

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Status

RECRUITING

Cancer Type

Hormone-Sensitive Prostate Cancer

Interventions

JSB462
Abiraterone
Enzalutamide

Locations (sample)

La Jolla, California, United States|32.84727,-117.2742
Santa Monica, California, United States|34.01949,-118.49138
Denver, Colorado, United States|39.73915,-104.9847
New Haven, Connecticut, United States|41.30815,-72.92816
Daytona Beach, Florida, United States|29.21081,-81.02283

Key Eligibility Criteria

An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2
Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible
High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non-nodal lesion and/or ≥4 metastatic bone lesions (with at least one lesion o…
Participants must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Ongoing ADT (as defined by prior orchiectomy and…

For full eligibility, visit ClinicalTrials.gov.

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