A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Running, not enrolling · Phase 2
Conditions studied: Prostatic Cancer, Castration-Resistant
In brief
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.
Key facts
- Study ID
- NCT07047118
- Run by
- Novartis Pharmaceuticals
- People needed
- 138
- Starts
- 2025-07-03
- Expected to finish
- 2028-05-14
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- 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
- 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
Full record on ClinicalTrials.gov
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