乳腺癌是威胁全球女性健康的第一大恶性肿瘤。其中，HER2低表达的乳腺癌患者占全部类型的45%~55%，但由于缺乏针对性的靶向治疗选择， HER2低表达的患者常被确诊为HER2阴性乳腺癌，而在传统治疗手段下，患者的生存时间和生存质量仍面临诸多挑战。Zhengda Tianqing has initiated a Phase III clinical study of injection TQB2102, targeting locally advanced or metastatic breast cancer patients with low expression of HER2 who have not received chemotherapy in the recurrent metastatic stage.
According to the latest information from the official website of the Chinese Clinical Trial Registration and Information Publicity Platform, Zhengda Tianqing has initiated a Phase III clinical study of injection TQB2102, targeting locally advanced or metastatic breast cancer patients with low expression of HER2 who have not received chemotherapy in the recurrent metastatic stage. The study plans to enroll 542 subjects in 125 research centers in China. Public information shows that TQB2102 is an antibody-drug conjugate (ADC) targeting two non-overlapping epitopes of HER2.
Screenshot source: China Drug Clinical Trial Registration and Information Disclosure Platform official website
Breast cancer is the leading malignant tumor threatening the health of women worldwide. Among them, breast cancer patients with low expression of HER2 account for 45% to 55% of all types, but due to the lack of targeted treatment options, patients with low expression of HER2 are often diagnosed as HER2-negative breast cancer. Under traditional treatment methods, patients still face many challenges in terms of survival time and quality of life.
According to an earlier press release from Sino Biopharm, TQB2102 is a bispecific antibody-drug conjugate (ADC) that targets two non-overlapping epitopes of HER2, ECD2 and ECD4. Compared to monoclonal antibodies and monoclonal antibody-drug conjugates, this HER2 bispecific ADC has stronger binding, internalization efficiency, and killing activity against tumor cells with low to moderate HER2 expression. At the same time, the dual epitope specificity and mechanism of action of ADC are expected to effectively address the resistance of monoclonal antibodies and monoclonal antibody-drug conjugates.