Study design and participants
tumor, adenocarcinomas
ONCOLOGY, TUMOR, ADENOCARCINOMAS
Participants in this phase 1, multicenter, open-label, exploratory study (NCT01671774) of zolbetuximab in combination with ZA and IL-2 were adults (aged ≥ 18 years) with refractory or recurrent histologically confirmed, advanced adenocarcinomas of the stomach, esophagus, or GEJ who had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. The study was conducted across nine sites in Germany and Latvia between October 2012 and October 2014. All patients underwent screening for CLDN18.2 expression; only patients with tumor samples with immunohistochemically confirmed higher and strong CLDN18.2 expression (3 + staining intensity, or 2 + staining intensity in ≥ 40% of tumor cells) were eligible. A complete list of inclusion and exclusion criteria is presented in Supplementary Table 1The primary study objectives were to explore the pharmacodynamics, including activation and kinetic profiles, of various immune cell populations (i.e., γ9δ2 T cells, NK cells, regulatory T [T