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ACTIVE NOT RECRUITING
NCT04662580
PHASE1

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

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.

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