Astellas has obtained the regulatory approval to go ahead with a global phase-3 clinical trial on investigational immunotherapy zolbetuximab in Korea.

The Ministry of Food and Drug Safety said it has given the green light to Parexel Korea, a contract research organization, to conduct two tests as part of the phase-3 study in Korea, one in July and the other on Friday.

Zolbetuximab is an experimental immunotherapy that kills cancer cells by binding to “Claudin (CLDN)-18.2,” a specific target antigen of gastric or gastroesophageal adenocarcinoma. The treatment is the first anticancer drug that binds specifically to CLDN-18.2.

Astellas is developing zolbetuximab as the first-line treatment for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

In Korea, Astellas will recruit patients with Claudin (CLDN) 18.2-positive, HER2 (human epidermal growth factor receptor 2)-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

A part of the study that won the nod in July was a randomized, double-blind trial to compare mFOLFOX6 (anticancer therapy)+placebo with mFOLFOX6+zolbetuximab. The trial is underway at Catholic University Seoul St. Mary's Hospital, Korea University Guro Hospital, Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Gachon University Gil Medical Center, Catholic University St. Vincent Hospital, and Bundang Seoul National University Hospital.

The trial approved on Friday is a randomized, double-blind study comparing CAPOX (anticancer therapy)+placebo with CAPOX+zolbetuximab. It will take place at CHA Bundang Medical Center, Korea University Guro Hospital, Ajou University Hospital, Chonbuk National University Hospital, SMG-SNU Boramae Medical Center, Hwasun Chonnam National University Hospital, National Cancer Center, and Chilgok Kyungpook National University Hospital.