132P A phase I clinical trial of QLS31905 in advanced solid tumors

作者：Yuyan Wang, J. Gong, Yuping Sun, S. Yang, Miao Zhang, Jiuwei Cui, Jing Lv, Haichuan Su, Jun Wang, Jin Lü, Jin Shan, J. Zhang, Yong Zhang, Yingchun Li, Liufang Gu, Li Li, Xiaoyan Kang, Lin Shen · 发表于：Immuno-Oncology Technology · 年份：2023 · DOI：10.1016/j.iotech.2023.100604 · 被引用次数：6 · 研究领域：Pancreatic and Hepatic Oncology Research、HER2/EGFR in Cancer Research、Glioma Diagnosis and Treatment

QLS31905 is a novel Claudin18.2/CD3 bi-specific antibody. This study aimed to evaluate its safety, tolerability, and antitumor activity in advanced solid tumors. This phase I trial (NCT05278832) recruited pts with advanced solid tumors who failed standard treatment, or were inapplicable to or had no standard treatment. The dose-escalation stage, adopting accelerated titration and interval 3+3 design, recruited pts regardless of Claudin 18.2 (CLDN18.2) expression. QLS31905 was administered in nine sequential single doses (0.5, 1.5, 5, 15, 45, 100, 200, 350, and 500 μg/kg qw or q2w) with/without priming dose. The dose-expansion stage recruited CLDN18.2-positive pts (expression ≥1% of tumor cells). The primary endpoint was dose limiting toxicities (DLT) and maximum tolerated dose (MTD) in dose-escalation stage, and was objective response rate (ORR) in dose-expansion stage. As of July 17, 2023, 52 pts were included. In dose-escalation stage, 22 pts were included from 0.5 to 350 μg/kg qw, and 500 μg/kg q2w cohort is ongoing. Two dose-expansion cohorts, 200 μg/kg qw or 350 μg/kg q2w, included 30 pts. Of 52 pts, 31 had gastric or gastro-esophageal junction cancer and 12 had pancreatic cancer (PC). DLT did not occur. MTD was not reached. Treatment-related adverse events (TRAEs) occurred in 51 pts (98.08%), of which 21 (40.38%) were ≥grade 3. Treatment-related serious adverse events (AEs) occurred in 10 (19.23%) pts. Two pts (3.85%) discontinued treatment due to AEs. The most common T...