Abstract
Background: HER3 is a key dimerization partner for HER-family members that activates oncogenic signaling pathways. U3-1287 is a fully human anti-HER3 monoclonal antibody that has demonstrated anticancer activity in preclinical models. In a preceding Japanese phase I study, the tolerability of U3-1287 was evaluated up to the dose of 18 mg/kg without dose-limiting toxicities (DLTs). This study aimed to assess the safety, pharmacokinetics and recommended dose of U3-1287 in combination with erlotinib for Japanese patients with advanced non-small cell lung cancer (NSCLC).
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