China-based Antengene Corporation Ltd (HKG: 6996) has received approval from Australia’s Therapeutic Goods Administration (TGA) to commence the Phase I CLINCH study for its antibody-drug conjugate (ADC) ATG-022. The study targets advanced or metastatic solid tumors, with a focus on gastric cancer patients expressing Claudin 18.2.
ATG-022: Mechanism and Preclinical Data
ATG-022 is an ADC designed to target Claudin 18.2, a protein frequently overexpressed in gastric cancer. Preclinical studies demonstrated that ATG-022, in combination with Claudin 18.2, exhibited a strong anti-tumor effect both in vitro and in vivo. Notably, the treatment showed efficacy even in models with low Claudin 18.2 expression, suggesting broad potential use across gastric cancer patients with varying expression levels. Additionally, ATG-022 demonstrated favorable safety profiles in toxicological studies.
Clinical Trial Objectives
The Phase I CLINCH study aims to evaluate the safety, tolerability, and preliminary efficacy of ATG-022 in patients with advanced or metastatic solid tumors. The trial will enroll participants in Australia, marking a significant step in Antengene’s global development strategy for this promising ADC.-Fineline Info & Tech
