The China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Adcentrx Therapeutics’ new Antibody-Drug Conjugate (ADC), ADRX-0405, paving the way for clinical trials in China for patients with advanced solid tumours, including prostate cancer.
The IND clearance allows China-based clinical centres to participate in the company’s ongoing Phase 1a/1b trial (NCT06710379), which is evaluating ADRX-0405 in patients with late-stage solid tumours, including metastatic castration-resistant prostate cancer, gastric cancer, and non-small cell lung cancer.
ADRX-0405 is a potential first-in-class, next-generation ADC targeting STEAP1 (six-transmembrane epithelial antigen of the prostate 1), a cell surface protein that is overexpressed in prostate cancer and certain other cancers, with limited expression in healthy tissue.
The therapy combines a humanized IgG1 antibody with a novel topoisomerase inhibitor linker- payload using Adcentrx’s innovative i-Conjugation technology platform. A core element of its ADC design, the platform uses stable conjugation chemistry and a cleavable linker designed to improve payload delivery directly to tumours. According to the company, the technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumours.
Preclinical studies of ADRX-0405 have demonstrated encouraging pharmacokinetics, a favourable safety profile, and significant efficacy across multiple animal tumour models.
Hui Li, Founder and CEO of Adcentrx, described the NMPA clearance of the ADRX-0405 IND as another important milestone for the company.
“This clearance expands our ability to enroll patients in both the US and China, broadening geographic representation and allowing us to generate clinical data across more diverse patient populations. This enables ADRX-0405 to address important unmet needs across multiple tumour types,” Li said.
The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label, multicenter dose escalation and dose expansion study designed to evaluate the safety, tolerability, and optimal dose of ADRX-0405 in patients with advanced solid tumours. Adcentrx expects to complete the Phase 1a portion of the study by the fourth quarter of 2026.
Based in San Diego, California, Adcentrx is a clinical-stage biotechnology company focused on developing ADC therapies for cancer and other life-threatening diseases.
