An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Recruiting now · Phase 2
Conditions studied: Metastatic Hormone-sensitive Prostate Cancer
In brief
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
Key facts
- Study ID
- NCT06991556
- Run by
- Novartis Pharmaceuticals
- People needed
- 150
- Starts
- 2025-07-07
- Expected to finish
- 2035-10-19
- Last updated by the study team
- 2026-06-10
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Saint Johns Cancer Institute — Santa Monica, California, United States (enrolling)
- Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Advanced Urology Ins Daytona Beach — Daytona Beach, Florida, United States (enrolling)
- Emory University School of Medicine-Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
- Associated Urological Specialists — Chicago Ridge, Illinois, United States (enrolling)
- American Oncology Partners PA Center for Cancer and Blood Disorders — Bethesda, Maryland, United States (enrolling)
- Mass General Hospital — Boston, Massachusetts, United States (enrolling)
- Michigan Institute of Urology — West Bloomfield, Michigan, United States (enrolling)
- XCancer Omaha LLC — Omaha, Nebraska, United States (enrolling)
- Perlmutter Cancer Centre — New York, New York, United States (enrolling)
- Associated Med Professionals of NY — Syracuse, New York, United States (enrolling)
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States (enrolling)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
- Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
- Urology San Antonio — San Antonio, Texas, United States (enrolling)
- Virginia Oncology Associates — Norfolk, Virginia, United States (enrolling)
- Fred Hutch Cancer Research — Seattle, Washington, United States (enrolling)
- Novartis Investigative Site — Adelaide, South Australia, Australia (enrolling)
- Novartis Investigative Site — Clayton, Victoria, Australia (enrolling)
- Novartis Investigative Site — Fortaleza, Ceará, Brazil (enrolling)
- Novartis Investigative Site — São Paulo, São Paulo, Brazil (enrolling)
- University of California San Diego - Moores Cancer Center — La Jolla, California, United States (enrolling)
Full record on ClinicalTrials.gov
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