China NMPA grants IND clearance to ADRX-0405 for advanced Solid tumors and Prostate cancer

CAR-T Digest - August 2020

08 June 2026: China NMPA grants IND clearance to ADRX-0405 for advanced Solid tumors including Prostate cancer

Adcentrx Therapeutics has received Investigational New Drug clearance from China’s National Medical Products Administration for ADRX-0405, enabling clinical development of the STEAP1-targeted antibody-drug conjugate in patients with late-stage solid tumors, including prostate cancer
The clearance expands the global development footprint of, which is already being evaluated in an ongoing phase 1 study for advanced solid tumors and is designed to address cancers with high STEAP1 expression and limited treatment options
ADRX-0405 is a next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1, a cell-surface protein highly expressed in prostate cancer and several other malignancies while demonstrating limited expression in normal tissues
The ADC utilizes Adcentrx’s proprietary i-Conjugation platform, combining a humanized anti-STEAP1 antibody with a cleavable linker and a topoisomerase I inhibitor payload at a drug-to-antibody ratio of 8, a design intended to maximize payload delivery while maintaining ADC stability
Strategically, the NMPA IND clearance strengthens Adcentrx’s presence in the rapidly evolving ADC landscape and expands development opportunities for STEAP1-targeted therapies beyond prostate cancer, positioning ADRX-0405 as a potential first-in-class asset in a target space with growing interest and limited clinical competition