A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

PHASE2RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

July 3, 2025

Primary Completion Date

February 14, 2028

Study Completion Date

December 11, 2028

Conditions
Prostatic Cancer, Castration-Resistant
Interventions
DRUG

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

DRUG

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

Trial Locations (12)

2010

RECRUITING

Novartis Investigative Site, Darlinghurst

3004

RECRUITING

Novartis Investigative Site, Melbourne

5000

RECRUITING

Novartis Investigative Site, Adelaide

13273

RECRUITING

Novartis Investigative Site, Marseille

15232

RECRUITING

Univ of Pittsburgh Cancer Institute, Pittsburgh

68130

RECRUITING

XCancer Omaha LLC, Omaha

168583

RECRUITING

Novartis Investigative Site, Singapore

3109601

RECRUITING

Novartis Investigative Site, Haifa

5265601

RECRUITING

Novartis Investigative Site, Ramat Gan

9103102

RECRUITING

Novartis Investigative Site, Jerusalem

03722

RECRUITING

Novartis Investigative Site, Seoul

05505

RECRUITING

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY