Adcentrx Therapeutics, a California-based clinical-stage biotechnology company advancing Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, announced on Monday that the China National Medical Products Administration (NMPA) has cleared Adcentrx's Investigational New Drug (IND) application for ADRX-0405.

The clearance enables the company to include China-based clinical centres in its ongoing Phase 1a/1b trial (NCT06710379) evaluating ADRX-0405 in patients with late-stage solid tumours, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer.

Adcentrx says that ADRX-0405 is a potential first-in-class, next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is overexpressed in prostate cancer and certain other cancers, with limited expression in healthy tissue.

The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label, multicentre dose escalation and dose expansion study. The study is enrolling patients with select advanced solid tumours. The primary objectives of the study are to characterise the safety and tolerability and to determine the optimal dose of ADRX-0405.

According to Adcentrx, ADRX-0405 preclinical studies have demonstrated its favourable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumour models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial, and the company anticipates completing the Phase 1a portion of the trial by the fourth quarter of 2026.