A multicenter, phase 1 study of AB011, a recombinant humanized anti-CLDN18.2 monoclonal antibody, as monotherapy and combined with capecitabine and oxaliplatin (CAPOX) in patients with advanced solid tumors.

作者：Jin Li, Hongming Pan, Tianshu Liu, Nong Xu, Yanqiao Zhang, Yanru Qin, Jianhua Shi, Dongcheng Liao, Lin Shen, Suxia Luo, Yueyin Pan, Wei Zhao, Yu Zheng, Rongyuan Zhuang, Chenyu Mao, Yue Ma, Huamao Wang, Zonghai Li · 发表于：Journal of Clinical Oncology · 年份：2023 · DOI：10.1200/jco.2023.41.4_suppl.391 · 被引用次数：13 · 研究领域：Barrier Structure and Function Studies、Mycobacterium research and diagnosis、Helicobacter pylori-related gastroenterology studies

391 Background: Claudin18.2 (CLDN18.2) is normally confined in tight junction of the gastric mucosa, but is also often expressed in several cancer types. AB011 is a humanized, anti-CLDN18.2 monoclonal antibody (IgG1), which has shown impressive therapeutic synergy between AB011 and cytotoxic agents in preclinical research. Here we report the preliminary data on AB011 both as monotherapy and combined with CAPOX in patients with advanced solid tumors (AB011-ST-01, NCT04400383). Methods: The primary objectives were to evaluate the safety and preliminary efficacy of AB011 as monotherapy (Part 1) and AB011 plus chemotherapy (Part 2) in advanced solid tumors. In part 1, patients with CLDN18.2 positive, treatment-refractory advanced gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA) and pancreatic cancer (PC) were enrolled. AB011 dose levels from 1mg/kg to 30mg/kg were explored using i3 + 3 design in dose-escalation stage, and in dose-expansion stage, 20mg/kg and 30mg/kg were further evaluated. In part 2, patients with advanced GC/GEJA were eligible if they had measurable lesions and positive CLDN18.2 expression (IHC 2+/3+ ≥ 40%). AB011 dose levels of 20mg/kg and 30mg/kg were explored using 3 + 3 design. Data are reported as of Sep06, 2022. Results: [Part 1] From Aug 2020 to Aug 2021, 14 pts were treated with AB011 at 1, 3, 10, 20 and 30mg/kg in dose-escalation stage, and 21 pts in dose-expansion stage (10 at 20mg/kg and 11 at 30mg/kg). 77.1% had received ≥ 2 prior li...