Antengene Corporation Limited announced that China’s Center for Drug Evaluation (CDE) has endorsed the launch of the pivotal Phase III CLINCH-3 study of ATG-022, a Claudin 18.2 antibody–drug conjugate, in patients with CLDN18.2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The multinational, randomized, controlled, open-label trial will begin in China and expand as a multi-regional clinical trial (MRCT).

CLINCH-3 is structured to compare ATG-022 monotherapy against an investigator’s choice of treatment. Co-primary endpoints are progression-free survival assessed by an independent review committee and overall survival. Key secondary measures include objective response rate, duration of response, disease control rate and safety. Results from this study are intended to support a future marketing application for ATG-022 in the targeted patient population.

ATG-022 is one of several first-in-class or best-in-class assets in Antengene’s pipeline, which spans preclinical to commercial stages and includes programs such as ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 × 4-1BB bispecific antibody) and multiple T-cell engagers developed on the proprietary AnTenGager platform.

Management cautioned that successful development and commercialization of ATG-022 are not guaranteed and advised shareholders and prospective investors to exercise caution when trading the company’s shares.