CLDN18.2 - ADC

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恒瑞CLDN18.2-ADC治疗晚期胃癌的1期临床数据登上Nature Medicine,中山大学徐瑞华团队领衔
生物世界· 2025-07-17 03:26
Core Viewpoint - CLDN18.2 is identified as a potential therapeutic target for gastric cancer and gastroesophageal junction adenocarcinoma, with the antibody-drug conjugate SHR-A1904 showing promising results in a Phase 1 clinical trial [1][4]. Group 1: Clinical Trial Overview - The Phase 1 clinical trial evaluated SHR-A1904 in 95 patients with advanced gastric or gastroesophageal junction cancer who were CLDN18.2 positive [4]. - The trial included a dose escalation phase (0.6–8.0 mg/kg), with dose-limiting toxicities observed at 4.8 mg/kg and 6.0 mg/kg, but the maximum tolerated dose was not reached [4]. - Common treatment-related adverse events included anemia (75.8%), nausea (67.4%), hypoalbuminemia (64.2%), and leukopenia (58.9%) [4]. Group 2: Efficacy Results - In patients with assessable efficacy, the confirmed objective response rate was 24.2% for the 6.0 mg/kg dose group and 25.0% for the 8.0 mg/kg dose group [5]. - The median progression-free survival was 5.6 months for the 6.0 mg/kg group and 5.8 months for the 8.0 mg/kg group [5]. Group 3: Research Team - The paper was co-authored by Dr. Xu Ruihua and Dr. Qiu Miaozhen from Sun Yat-sen University Cancer Prevention and Treatment Center, along with other contributors [6].