[Translation] A Phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of HL07/WBP297 in patients with RAS wild-type advanced metastatic colorectal cancer
I期主要目的:评价重组EGFR全人源单克隆抗体注射液(HL07)在RAS野生型的晚期转移性结直肠癌患者中的安全性、耐受性,确定剂量限制性毒性(DLT)及剂量组扩展阶段(II期)推荐剂量 II期主要目的:评价重组EGFR全人源单克隆抗体注射液(HL07)在RAS野生型的晚期转移性结直肠癌患者中的有效性。
[Translation] The main purpose of Phase I is to evaluate the safety and tolerability of recombinant EGFR fully human monoclonal antibody injection (HL07) in patients with RAS wild-type advanced metastatic colorectal cancer, and to determine the dose-limiting toxicity (DLT) and the recommended dose for the dose group expansion phase (Phase II). The main purpose of Phase II is to evaluate the efficacy of recombinant EGFR fully human monoclonal antibody injection (HL07) in patients with RAS wild-type advanced metastatic colorectal cancer.