ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

December 9, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

December 29, 2028

Conditions
Metastatic Prostate Cancer
Interventions
DRUG

ARX517

ARX517 is an ADC consisting of a humanized anti-PSMA monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two (2) proprietary microtubule-disrupting toxins referred to as AS269.

DRUG

Apalutamide

Oral tablet and will be given once daily by mouth.

DRUG

Abiraterone acetate

Oral tablet and will be given once daily by mouth.

DRUG

Prednisone

Oral tablet and will be given once daily in metastatic castration-sensitive prostate cancer( mCSPC) and twice daily in metastatic castration-resistant prostate cancer (mCRPC) cohort by mouth.

Trial Locations (12)

29572

RECRUITING

Carolina Urologic Research Center, Myrtle Beach

30322

RECRUITING

Winship Cancer Institute of Emory University, Atlanta

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

63110

RECRUITING

Washington University St. Louis School Medicine Siteman Cancer Center, St Louis

68130

COMPLETED

GU Research Network, Omaha

92093

RECRUITING

UC San Diego Moores Cancer Center, La Jolla

98101

RECRUITING

University of Washington, Seattle

90095-3000

RECRUITING

University of California, Los Angeles School of Medicine, Los Angeles

94143-2350

RECRUITING

UCSF Medical Center at Mission Bay, San Francisco

46202-5116

RECRUITING

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

48109-5000

RECRUITING

University of Michigan Comprehensive Cancer Center, Ann Arbor

10021-5663

RECRUITING

Weill Cornell Medical College, New York

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY