An open-label phase Ib/II study of trastuzumab deruxtecan combined with nivolumab and CAPOX for HER2-low gastroesophageal adenocarcinoma

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Background: Trastuzumab deruxtecan (T-DXd) is the standard of care for previously treated patients with HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA). Exploratory analyses of the DESTINY-Gastric01 trial suggested preliminary antitumor activity of T-DXd in HER2-low mGEA. Additionally, preclinical studies have reported a synergistic effect between T-DXd and anti-programmed cell death protein 1 antibodies. Therefore, T-DXd combined with nivolumab and chemotherapy may provide therapeutic benefits for patients with HER2-low mGEA. Trial design: , day 1), every 3 weeks. The primary endpoints are the dose-limiting toxicity rate in phase Ib and the objective response rate (ORR) in phase II. Hypothesis testing assumes a null ORR of 58% and an alternative ORR of 80%. The planned sample size is 28 patients treated with RP2D.

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