Updated Safety and Efficacy Analysis of Givastomig in Advanced Gastroesophageal Carcinoma

I-MAB reported updated safety, efficacy, and biomarker data from the Phase I monotherapy study of Givastomig, a novel Claudin 18.2/4-1BB bispecific antibody, in patients with Claudin 18.2 positive advanced gastroesophageal carcinoma (GEC). The study, which included 45 patients, showed that Givastomig was well tolerated up to 15 mg/kg Q2W and 18 mg/kg Q3W, with no dose-limiting toxicities observed. The confirmed overall response rate (ORR) was 18%, and the disease control rate (DCR) was 48.9%. No statistically significant differences in ORR, DCR, progression-free survival (PFS), or overall survival (OS) were observed between patients with high and low Claudin 18.2 expression. The findings support the continued development of Givastomig as a potential treatment for advanced or metastatic GEC, including in combination with nivolumab and mFOLFOX6.