Pharmews

上市前夕（ 2020.11.05 ），荣昌生物制药在 clinicaltrials.org 公示最新 c-Met ADC 治疗产品 RC108 的 I 期临床方案，用于 c-Met 阳性晚期恶性实体瘤 的治疗。 A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Effect of RC108-ADC For Injection in Subjects With c-Met Positive Advanced Malignant Solid Tumors This study consists of two parts. Part one is an escalation study, which will evaluate the safety, pharmacokinetics, and effect of RC108-ADC for injeciton in subjects with c-Met positive advanced malignant solid tumors. Part two is an expansion study, which will evaluate the effect, safety, and pharmacokinetics of RC108-ADC for injeciton in subjects with c-Met positive advanced malignant solid tumors. Participants will be allocated to one of the following dose groups: 0.1, 0.3, 0.9, 1.5, 2.0, 2.5, and 3.0mg/kg, and receive a treatment of RC108-ADC followed by 28 days of dose limited toxicity (DLT) observation period. 该临床计划在国内开展，目前公示临床试验中心为国家癌症中心 / 中国医学科学院北京协和医学院肿瘤医院， PI 为石远凯，计划入组 32 位受试者，计划可于 2021 年 4 月 15 日开展，预期首要完成日期为 2025...