Antengene initiates Phase II dose expansion study of Claudin 18.2 antibody-drug conjugate in China and Australia

"On March 20th, Antengene Pharmaceuticals Limited announced the official initiation of the dose expansion phase of the Phase II CLINCH study in China and Australia, aimed at evaluating ATG-022 (Claudin 18.2 antibody-drug conjugate) as a monotherapy in patients with advanced or metastatic solid tumors. The ongoing CLINCH study has already collected excellent preliminary clinical data, with patients achieving both partial response (PR) and complete response (CR). The CLINCH study is a multicenter, open-label Phase I/II trial conducted in patients with advanced or metastatic solid tumors, divided into dose escalation and dose expansion stages. The trial's primary objective is to evaluate the safety and tolerability of ATG-022 monotherapy to confirm the maximum tolerated dose (MTD) of ATG-022 and the recommended Phase II dose (RP2D). Secondary objectives include assessing the pharmacokinetics and preliminary efficacy of ATG-022. In the dose expansion phase, the study plans to enroll patients with gastric cancer and other solid tumors. In May 2023, the U.S. Food and Drug Administration (FDA) granted ATG-022 orphan drug designations (ODDs) for the treatment of pancreatic cancer and gastric cancer. Dr. Zhang Xiaojing, Chief Medical Officer of Antengene Pharmaceuticals, stated, "We are very pleased to successfully initiate the dose expansion phase of the Phase II CLINCH study for ATG-022 in China and Australia. The preclinical and preliminary clinical data are encouraging, with two patients with advanced metastatic gastric cancer achieving PR and CR, respectively. Following the initiation of this important phase of the study, Antengene Pharmaceuticals will continue to maintain close collaboration with regulatory authorities and clinical researchers, continuously exploring the path to fully evaluate the clinical potential of ATG-022."