NCT06991556 - An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) | Biotech Hunter

Enrollment

150

Participants

Timeline

Start Date

July 7, 2025

Primary Completion Date

February 26, 2032

Study Completion Date

September 17, 2035

Conditions

Metastatic Hormone-sensitive Prostate Cancer

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (26)

3168

RECRUITING

Novartis Investigative Site, Clayton

5000

RECRUITING

Novartis Investigative Site, Adelaide

20246

RECRUITING

Novartis Investigative Site, Hamburg

23502

RECRUITING

Virginia Oncology Associates, Norfolk

27003

RECRUITING

Novartis Investigative Site, Lugo

29572

RECRUITING

Carolina Urologic Research Center, Myrtle Beach

37134

RECRUITING

Novartis Investigative Site, Verona

37203

RECRUITING

Sarah Cannon Research Institute, Nashville

68130

RECRUITING

XCancer Omaha LLC, Omaha

70403

RECRUITING

Novartis Investigative Site, Tainan City

78229

RECRUITING

Urology San Antonio, San Antonio

80218

RECRUITING

Rocky Mountain Cancer Centers, Denver

92150

RECRUITING

Novartis Investigative Site, Suresnes

119074

RECRUITING

Novartis Investigative Site, Singapore

169608

RECRUITING

Novartis Investigative Site, Singapore

656 53

RECRUITING

Novartis Investigative Site, Brno

06189

RECRUITING

Novartis Investigative Site, Nice

8025 AB

RECRUITING

Novartis Investigative Site, Zwolle

2134 TM

RECRUITING

Novartis Investigative Site, Hoofddorp

25-640

RECRUITING

Novartis Investigative Site, Kielce

32-600

RECRUITING

Novartis Investigative Site, Oświęcim

60-185

RECRUITING

Novartis Investigative Site, Skorzewo

S308433

RECRUITING

Novartis Investigative Site, Singapore

03080

RECRUITING

Novartis Investigative Site, Seoul

06351

RECRUITING

Novartis Investigative Site, Seoul

06080

RECRUITING

Novartis Investigative Site, Badajoz