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An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Sponsor: Novartis Pharmaceuticals
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
Official title: 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)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-07-07
Completion Date
2035-10-19
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
JSB462
JSB462 is administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Abiraterone
Abiraterone 1000 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Enzalutamide
Enzalutamide 160 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Locations (61)
University of California San Diego - Moores Cancer Center
La Jolla, California, United States
Saint Johns Cancer Institute
Santa Monica, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Advanced Urology Ins Daytona Beach
Daytona Beach, Florida, United States
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, United States
American Oncology Partners PA Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Mass General Hospital
Boston, Massachusetts, United States
Michigan Institute of Urology
West Bloomfield, Michigan, United States
XCancer Omaha LLC
Omaha, Nebraska, United States
Perlmutter Cancer Centre
New York, New York, United States
Associated Med Professionals of NY
Syracuse, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Urology San Antonio
San Antonio, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Fred Hutch Cancer Research
Seattle, Washington, United States
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Beijing, Chaoyang, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Olomouc, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Nice, Alpes Maritimes, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Quint-Fonsegrives, France
Novartis Investigative Site
Suresnes, France
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Lübeck, Germany
Novartis Investigative Site
Nürtingen, Germany
Novartis Investigative Site
Asti, AT, Italy
Novartis Investigative Site
Padova, PD, Italy
Novartis Investigative Site
Trento, TN, Italy
Novartis Investigative Site
Orbassano, TO, Italy
Novartis Investigative Site
Verona, VR, Italy
Novartis Investigative Site
Zwolle, Overijssel, Netherlands
Novartis Investigative Site
Dordrecht, South Holland, Netherlands
Novartis Investigative Site
Hoofddorp, Netherlands
Novartis Investigative Site
Schiedam, Netherlands
Novartis Investigative Site
Kielce, Poland
Novartis Investigative Site
Olsztyn, Poland
Novartis Investigative Site
Oświęcim, Poland
Novartis Investigative Site
Skorzewo, Poland
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Santander, Cantabria, Spain
Novartis Investigative Site
Badajoz, Extremadura, Spain
Novartis Investigative Site
Lugo, Galicia, Spain
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Córdoba, Spain
Novartis Investigative Site
Kaohsiung City, Taiwan
Novartis Investigative Site
Tainan, Taiwan