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A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Sponsor: Novartis Pharmaceuticals
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.
Official title: A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Lutetium (177Lu) Vipivotide Tetraxetan in Adult Male Patients With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2025-07-03
Completion Date
2028-11-04
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
JSB462
Administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
AAA617
administered at 7.4 GBq intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
Locations (47)
City of Hope National Medical
Duarte, California, United States
Providence Saint Johns Health Ctr
Santa Monica, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Indiana University
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
XCancer Omaha LLC
Omaha, Nebraska, United States
NYU Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Univ of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States
Urology San Antonio
San Antonio, Texas, United States
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Innsbruck, Tyrol, Austria
Novartis Investigative Site
Linz, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Burnaby, British Columbia, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Olomouc, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Brest, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Tours, France
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Rostock, Germany
Novartis Investigative Site
Afula, Israel
Novartis Investigative Site
Beersheba, Israel
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Petah Tikva, Israel
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Nijmegen, Gerlderland, Netherlands
Novartis Investigative Site
Hoofddorp, Netherlands
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Granada, Andalusia, Spain
Novartis Investigative Site
El Palmar, Murcia, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Seville, Spain
Novartis Investigative Site
Taipei, Taiwan