[Translation] An open-label, multicenter, dose-escalation Phase I clinical study to explore the safety, tolerability, pharmacokinetics/pharmacodynamics and preliminary efficacy of intratumoral injection of KM1 monotherapy in subjects with advanced malignant solid tumors whose disease has progressed after standard treatment or who are intolerant to chemotherapy or have no standard treatment
本研究是治疗晚期恶性实体瘤成人受试者的开放性、多中心、剂量递增的I期临床研究,目的是评价KM1单药瘤内注射在经标准治疗后疾病进展或对化疗不耐受或无标准治疗的晚期恶性实体瘤受试者中的安全性、耐受性、PK/PD及初步疗效,确定MTD及推荐的II期临床研究剂量(RP2D)。
[Translation] This study is an open-label, multicenter, dose-escalation Phase I clinical study for the treatment of adult subjects with advanced malignant solid tumors. The purpose is to evaluate the safety, tolerability, PK/PD and preliminary efficacy of KM1 monotherapy injected intratumorally in subjects with advanced malignant solid tumors whose disease has progressed after standard treatment or who are intolerant to chemotherapy or have no standard treatment, and to determine the MTD and recommended Phase II clinical study dose (RP2D).