Cancer cell · 2025
TROP-2-targeted antibody-drug conjugate SHR-A1921 for advanced or metastatic solid tumors: A first-in-human phase 1 study.
СтатьяКлиническое исследование I фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Zhong Jia, Wu Lin, Song Zhengbo, Xing Nianzeng, Cui Jiujie, Li Xingya, Fei Kailun, Tang Dihong, Dang Qi, Chen Liang, Liu Tianshu, Liu Caigang, Li Yong, Zhang Shichuan, Han Xinghua, Xiao Juxiang, Guo Feng, Yan Min, Xu Huiting, Yuan Chunxiu, Zhong Jincai, Liu Rongrui, Qu Xiujuan, Wu Shikai, Jiang Shusuan, Yang Yan, Zhang Panpan, Guo Hongqian, Wang Ce, Xie Qiushi, Lin Zhifei, Wang Shuni, Wang Jie
Аннотация
This study is a first-in-human, three-stage, phase 1 trial (NCT05154604) designed to evaluate the trophoblast cell-surface antigen 2 (TROP-2)-targeted antibody-drug conjugate SHR-A1921 (1.5-6.0 mg/kg every 3 weeks) in 391 patients with pretreated advanced/metastatic solid tumors. Grade ≥3 treatment-related adverse events occurred in 132 patients (33.8%), with the most common being stomatitis, affecting 57 patients (14.6%). SHR-A1921 showed a low incidence of hematologic toxicities, with only 3.1% of patients experiencing grade ≥3 decreases in neutrophil count. The overall objective response rate was 24.8% (95% confidence interval [CI], 20.6-29.4), ranging from 18.2% to 43.1% across cohorts with platinum-resistant ovarian cancer, triple-negative breast cancer, small-cell lung cancer, non-small cell lung cancer, hormone receptor-positive breast cancer, cervical cancer, and biliary tract cancer. No significant correlation was found between TROP-2 expression and treatment efficacy. In summary, SHR-A1921 exhibited promising antitumor activity and a manageable safety profile, with 3.0 mg/kg every 3 weeks selected for further clinical development.