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ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
Sponsor: Janssen Research & Development, LLC
Summary
This is a phase 1 study to assess the safety and tolerability of ARX517 as monotherapy or combination therapy in adult subjects with metastatic prostate cancer (mPC).
Official title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of ARX517 as Monotherapy and in Combination With Androgen Receptor Pathway Inhibitors in Subjects With Metastatic Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
183
Start Date
2021-05-03
Completion Date
2026-12-31
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
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.
Apalutamide
Oral tablet and will be given once daily by mouth.
Abiraterone acetate
Oral tablet and will be given once daily by mouth.
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.
Locations (12)
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of California, Los Angeles School of Medicine
Los Angeles, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Washington University St. Louis School Medicine Siteman Cancer Center
St Louis, Missouri, United States
GU Research Network
Omaha, Nebraska, United States
Weill Cornell Medical College
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
University of Washington
Seattle, Washington, United States