Led by principal investigator Professor Lin Shen of Peking University Cancer Hospital, the randomized, open-label study evaluates the efficacy and safety of the drug compared to standard investigator-selected treatments. The transition to this late-stage trial follows encouraging results from Phase I/II studies, which demonstrated a 46.7% objective response rate in patients with moderate to high CLDN18.2 expression at the recommended 1.8 mg/kg dose.

Safety data remains a focal point for the development team. Despite six additional months of follow-up, the incidence of Grade 3 or higher treatment-related adverse events in the 1.8 mg/kg cohort remained stable at 21.0%. With Breakthrough Therapy Designation from China’s National Medical Products Administration already secured, the company is positioning ATG-022 as a potential best-in-disease option. Beyond the current monotherapy trial, Antengene is pursuing a multi-pronged clinical strategy that includes combination therapies in first-line settings and expansion into non-gastric solid tumors.