544 A phase I/II clinical trial of anti-CLDN18.2/PD-L1 recombinant humanized bispecific antibody Q-1802 combined with XELOX chemotherapy in untreated advanced GC/GEJ patients

作者：Yakun Wang, Jifang Gong, Jianwei Yang, Yuping Sun, Shuqin Ni, Yanqiao Zhang, Wenhui Yang, Yang Liu, Yiwen Zhang, Jiayi Li, Jinsheng Shi, Hongying Zhao, Tianshu Liu, Hongming Pan, Jingdong Zhang, Yanhong Deng, Xiaoge Kou, Peng Nie, Ye Chen, Xiangdong Qu, Lin Shen · 发表于：Regular and Young Investigator Award Abstracts · 年份：2025 · DOI：10.1136/jitc-2025-sitc2025.0544 · 被引用次数：1 · 研究领域：Monoclonal and Polyclonal Antibodies Research、Cancer Immunotherapy and Biomarkers、HER2/EGFR in Cancer Research

Background Q-1802 is the first recombinant humanized Claudin18.2/PD-L1-tagerting bispecific antibody consisting of a N-terminal Claudin 18.2 antibody and a C-terminal PD-L1 antibody simultaneously targeting Claudin18.2 on tumor cells and PD-L1 in the tumor microenvironment (TME). Meanwhile, it retains the full antibody Fc effector function comparable to IgG1, which can mediate antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.Methods This study is a multi-center, open-label, non-randomized parallel controlled phase I/II clinical trial (Qure-1802-201). Patients with untreated advanced GC/GEJ are administered with Q-1802 (IV, Q2W) respectively at 10 mg/kg and 20 mg/kg dose level in combination with XELOX standard chemotherapy (Oxaliplatin IV, d1 and capecitabine PO, d1-14, Q3W). The primary endpoint of phase I refers to safety and tolerability, while that of phase II is objective response rate (ORR) per RECIST v1.1.Results As of March 31, 2025, a total of 51 subjects with untreated advanced GC/GEJ were enrolled, 45 of which were in 10mg/kg of Q-1802 cohort and 6 were in 20mg/kg cohort. No dose-limiting toxicity (DLT) was observed and maximum tolerated dose (MTD) was not reached. Chemotherapy related treatment emergent adverse events (TEAEs) were consistent with historical data. The most common Q-1802 related TEAEs included nausea (72.5%), elevated aspartate aminotransferase (60.8%), vomiting (58.8%), and fatigue (51.0%)...