5 research outputs found
FAST: An international, multicenter, randomized, phase II trial of epirubicin, oxaliplatin, and capecitabine (EOX) with or without IMAB362, a first-in-class anti-CLDN18.2 antibody, as first-line therapy in patients with advanced CLDN18.2+ gastric and gastroesophageal junction (GEJ) adenocarcinoma
Background: Claudin18.2 (CLDN18.2) is a tight junction protein expressed by several cancers including
gastric and GEJ adenocarcinoma. IMAB362 is a chimeric monoclonal antibody that mediates specific
killing of CLDN18.2-positive cancer cells by activation of immune effector mechanisms. IMAB362 has
demonstrated single-agent activity and was safe and tolerable in patients (pts) with pretreated gastric
cancer. Methods: Pts with advanced/recurrent gastric and GEJ cancer were centrally evaluated for
CLDN18.2 expression by IHC (validated CLAUDETECT18.2 Kit). Eligible pts had a CLDN18.2 expression of ≥
2+ in ≥ 40% tumor cells, an ECOG PS of 0–1 and were not eligible for trastuzumab. Pts were randomized
1:1 to first-line EOX..