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AMG 305 is a bispecific T-cell engager (BiTE) monoclonal antibody developed by Amgen for the treatment of advanced solid tumors. It specifically targets tumor cells that co-express cadherin-3 (CDH3) and mesothelin (MSLN), while also binding to CD3 on cytotoxic T lymphocytes. This dual targeting enables the recruitment and activation of T cells to induce potent cytotoxicity against tumor cells expressing both CDH3 and MSLN antigens. Preclinical studies have shown dose-dependent antitumor activity in xenograft models, with good tolerability in non-human primates at exposure levels above predicted human efficacious doses. The drug is currently being evaluated in Phase 1 clinical trials for safety, tolerability, pharmacokinetics, and preliminary efficacy in adults with advanced solid tumors[1][2][3][4][5][6].
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