Antengene (HKG:6996) said the Center for Drug Evaluation of China's National Medical Products Administration endorsed a phase 3 study of ATG-022 in advanced gastric or gastroesophageal junction adenocarcinoma, according to a Thursday filing with the Hong Kong bourse.
The trial, called CLINCH-3, is expected to be initiated in China first and is planned as a multi-regional clinical trial.
The study is intended to support a future marketing approval application for ATG-022 as a monotherapy.