China-based Antengene Corporation Ltd (HKG: 6996) is poised to commence a Phase I clinical study to assess the safety and tolerability of ATG-022 in patients with advanced and metastatic solid tumors. The study will also determine the bioactive dose, maximum tolerable dose (MTD), and recommended Phase II dose (RP2D). ATG-022 is a Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) that previously obtained approval in Australia to start the Phase I CLINCH clinical trial.
Pre-Clinical Findings and Potential Applications
Pre-clinical data indicate that ATG-022 binds with CLDN18.2 with high affinity, delivering a potent anti-tumor effect both in vitro and in vivo. Notably, the in vivo effects were observed even in models with low CLDN18.2 expression, suggesting that ATG-022 could be suitable for a broad range of gastric cancer patients with varying levels of CLDN18.2 expression. Additionally, ATG-022 demonstrated a good safety profile in toxicological studies.
Significance of the Clinical Trial
The initiation of the Phase I clinical study marks a significant step forward in the development of ATG-022. This trial will provide crucial data on the drug’s safety and optimal dosing, paving the way for further clinical development and potentially expanding treatment options for patients with advanced solid tumors.-Fineline Info & Tech
