Antengene Corporation Limited, a prominent global biopharmaceutical entity focused on the development and commercialization of pioneering therapeutics in hematology and oncology, today announced the commencement of the dose expansion phase of the Phase II CLINCH study for its innovative therapy, ATG-022 (Claudin 18.2 antibody-drug conjugate [ADC]), in China and Australia. This milestone follows the achievement of promising preliminary clinical outcomes, including partial and complete responses, in the ongoing CLINCH trial.

The CLINCH study, designed as a multi-center, open-label Phase I/II trial, aims to evaluate ATG-022 monotherapy in patients with advanced or metastatic solid tumors. The primary goals are to assess the treatment's safety and tolerability, establish the maximum tolerated dose (MTD), and recommend a Phase II dose (RP2D). Additionally, the study seeks to characterize ATG-022's pharmacological profile and gauge its preliminary effectiveness.

With the initiation of the dose expansion phase, the study will now recruit patients diagnosed with gastric cancer or other solid tumors. This expansion is notably supported by two Orphan Drug Designations awarded by the U.S. Food and Drug Administration (FDA) in May 2023 for ATG-022's application in treating pancreatic and gastric cancers, respectively.

Dr. Amily Zhang, Chief Medical Officer at Antengene, expressed enthusiasm about progressing to the dose expansion phase in China and Australia, highlighting the trial's foundation on robust preclinical data and its initial success in demonstrating efficacy in metastatic gastric cancer cases. The advancement into this crucial phase signifies Antengene's commitment to exploring ATG-022's full clinical potential in collaboration with regulatory bodies and medical investigators.