Abstract CT168: EMB-01, an EGFR/cMET bispecific antibody, in metastatic colorectal cancer: Results from an international phase Ib/II study

作者：Lin Shen, Christine M. Parseghian, Yanqiao Zhang, Zhiyu Chen, Yanru Qin, Weisheng Zhang, Yanhong Deng, Hongming Pan, Shanzhi Gu, Changzheng Li, Rong Wang, Fang Ren, Qiaoyang Lu, Xiaodong Sun, Yonghong Zhu · 发表于：Cancer Research · 年份：2025 · DOI：10.1158/1538-7445.am2025-ct168 · 被引用次数：2 · 研究领域：Radiopharmaceutical Chemistry and Applications、Monoclonal and Polyclonal Antibodies Research、Colorectal Cancer Treatments and Studies

Abstract Background: Gastrointestinal (GI) cancers often overexpress epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (cMET). EMB-01, a bispecific tetravalent fully humanized wild-type IgG1 antibody targeting EGFR and cMET, has demonstrated antitumor activity in preclinical and clinical studies with a recommended phase 2 dose (RP2D) of 1600 mg once weekly1,2. This Phase Ib/II study (NCT05176665) evaluates EMB-01 monotherapy in GI cancers, including gastric, hepatocellular, biliary tract and colorectal cancer. Here, we report the preliminary safety and efficacy results in metastatic colorectal cancer (mCRC). Methods: This multicenter, single-arm, open-label study, conducted in China and the US, enrolled patients (pts) with heavily pretreated metastatic GI cancers. EMB-01 was intravenously administered at the RP2D. Response and safety were assessed by the investigator per RECIST v1.1 and CTCAE v5.0, respectively. Results: As of Dec 4, 2024, 48 mCRC pts with different EGFR/cMET expression or amplification status were enrolled. The median age was 60 years (range 41-77), Asian/White was 41/7, ECOG performance status 0/1 was 21/27, 68.8% were male and 91.7% were left-sided mCRC. The median lines of prior systemic therapies were 3 (range 1-11), with 66.7% having received prior anti-EGFR therapy, 79.2% anti-VEGF therapy, and 27.1% fruquintinib, regorafenib, or trifluridine/tipiracil (TAS-102). Among 44 pts evaluable for response, 29 were left-sided...