Phase 1 multicenter, dose-expansion study of ARX788 as monotherapy in HER2-positive advanced gastric and gastroesophageal junction adenocarcinoma

• DOI: 10.1016/j.xcrm.2022.100814
• Publication Date: 2022-11-16T05:01:54Z
• Authors: Yang Zhang; Miao-Zhen Qiu; Ju-Feng Wang; Yan-Qiao Zhang; Ao Shen; Xiang-Lin Yuan; Tao Zhang; Xiao-Li Wei; Hong-Yun Zhao; De-Shen Wang; Qi Zhao; Gao-Zhun Xiong; Yan-Ping Ji; Xue-Jun Liang; Gang Xia; Rui-Hua Xu
• Keywords: Gastric adenocarcinoma

ARX788 is an anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugate with AS269 as cytotoxic payload. In this phase 1 multicenter dose-expansion clinical trial, patients HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma failing to respond prior trastuzumab-based standard treatment were enrolled. Between July 15th, 2019, and March 14th, 2022, 30 participants Twenty-eight (93.3%) experienced at least one drug-related adverse event (AE) 13.3% grade 3 ARX788-related AEs. The confirmed objective response rate 37.9% (95% confidence interval [CI]: 20.7%–57.7%) the disease control 55.2% CI: 35.7%–73.6%). With a median follow up of 10 months, progression-free survival overall are 4.1 1.4–6.4) 10.7 months 4.8–not reached), respectively. duration 8.4 2.1–18.9) months. well tolerated has promising anti-tumor activity in gastric (ChinaDrugTrials.org.cn: CTR20190639).