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NBL-015 is a fully human monoclonal IgG1 antibody that targets the type 2 isoform of human Claudin 18 protein (Claudin 18.2), a tumor-associated antigen highly expressed in certain cancers, including gastric, gastroesophageal junction, and pancreatic cancers[1][2][5]. Engineered for enhanced antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP), it demonstrates high affinity for its target, low immunogenicity, and potent antitumor activity in preclinical models[5][6]. Developed as an investigational therapy for advanced solid tumors expressing CLDN18.2, it is currently being evaluated in Phase I clinical trials both as monotherapy and in combination with standard chemotherapy or PD‑1 inhibitors[7][8]. The drug has received orphan drug designation from the FDA for pancreatic cancer and gastric cancer (including gastroesophageal junction cancer)[4][5].
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