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

Phase 1 Active not recruiting 183 enrolled Janssen Research & Development, LLC

Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2021-05-03
Primary completion: 2026-12-31
Completion: 2026-12-31

Publications

Skidmore LK, Mills D, Kim JY, Knudsen NA, Nelson JD, Pal M, Wang J, Gc K, Gray MJ, Barkho W, Nagaraja Shastri P, Ramprasad MP, Tian F, O'Connor D, Buechler YJ, Zhang SS. Preclinical Characterization of ARX517, a Site-Specific Stable PSMA-Targeted Antibody-Drug Conjugate for the Treatment of Metastatic Castration-Resistant Prostate Cancer. Mol Cancer Ther. 2024 Dec 3;23(12):1842-1853. doi: 10.1158/1535-7163.MCT-23-0927.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARX517	Monoclonal antibody	—	Intravenous
Background	Abiraterone acetate	Small molecule	—	Oral
Background	Apalutamide	Small molecule	—	Oral
Background	Prednisone	Other / unclassified	—	Oral

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

Summary

Timeline

Publications

Drugs

Indications