Preliminary efficacy and safety of TQB2102 in patients with HER2 low-expressing recurrent/metastatic breast cancer: Results from a phase 1b study.

作者：Shusen Wang, Qingyuan Zhang, Jin Yang, Tao Sun, Shaoyan Lin, Yehui Shi, Jingfen Wang, Fei Luo, Xiujuan Qu, Huihui Li, Weimin Xie, Hongxue Wang, Chunjiao Wu, Changlu Hu, Hongwei Yang, Hong Wang, Fan Feng, Yang Yu, Jie Chen · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.1090 · 被引用次数：2 · 研究领域：HER2/EGFR in Cancer Research、Cancer Treatment and Pharmacology、Colorectal Cancer Treatments and Studies

1090 Background: TQB2102 is a novel antibody-drug conjugate (ADC) comprised of a recombinant humanized anti-HER2 bispecific antibody that simultaneously binds to two distinct HER2 epitopes (ECD4 and ECD2), an enzyme-cleavable linker, and a DNA topoisomerase I inhibitor payload. This study aims to evaluate the efficacy and safety of TQB2102 for patients (pts) with HER2-expressing relapsed/metastatic breast cancer. Methods: This 1b phase, open-label, multicenter, randomized trial was divided into two cohorts: Pts in cohort 1 were HER2 low-expressing breast cancer and in cohort 2 were HER2 positive BC, all pts were refractory or intolerant to standard therapy. In cohort 1, HER2 low-expressing pts were randomly assigned to receive TQB2102 monotherapy at a dose of 6.0 mg/kg (Q3W, IV) or 7.5 mg/kg (Q3W, IV). The primary endpoint was ORR per RECIST v1.1, and the secondary endpoints were PFS, DCR and safety etc. Results: 73 HER2 low-expressing female pts were randomized to receive at least one dose of TQB2102 6mg/kg (n = 37) or 7.5mg/kg (n = 36), the median age was 53. All pts had received chemotherapy in the metastatic setting, and hormone receptor positive pts (n = 50) also had received prior CDK4/6 inhibitors. In cohort 1, pts had undergone a median of 4 prior treatment lines (range: 1-10) in the metastatic setting, the median prior lines of chemotherapy therapies were 2 (range: 1-5), and 12.3% (n = 9) pts had received prior ADCs. As of data cutoff on Nov 1, 2024, median follow-up...