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Givastomig is a bispecific monoclonal antibody designed to target Claudin 18.2 (CLDN18.2) on tumor cells and conditionally activate T cells via the 4-1BB (CD137) signaling pathway within the tumor microenvironment where CLDN18.2 is expressed[3][5][6]. This dual mechanism enables selective activation of immune responses against CLDN18.2-positive tumors, such as gastric cancer, while minimizing systemic immunotoxicity commonly associated with broad 4-1BB agonists[5][6]. Givastomig has demonstrated strong tumor-binding properties and anti-tumor activity in preclinical models and early clinical trials, with ongoing Phase 1 studies evaluating its safety and efficacy as monotherapy or in combination with nivolumab plus chemotherapy for first-line metastatic gastric cancers and other solid tumors[1][4][5]. The drug was developed through a collaboration between I-Mab (China/US) and ABL Bio (South Korea), with Orphan Drug Designation granted by the FDA for gastric cancer including gastroesophageal junction cancer[5].
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