[Translation] A first-in-human, open-label, single-arm, dose-escalating Phase I clinical trial of UCMYM802 injection in patients with MSLN-positive advanced solid tumors
主要目的:评价UCMYM802注射液治疗MSLN阳性晚期恶性实体肿瘤患者的安全性和耐受性;确定UCMYM802注射液治疗MSLN阳性晚期恶性实体肿瘤患者的最大耐受剂量(MTD)和II期推荐剂量(RP2D)。
次要目的:评价UCMYM802注射液在受试者体内的药物代谢动力学特征;评价UCMYM802注射液在受试者体内的药效动力学特征;评价UCMYM802注射液的免疫原性;评价UCMYM802注射液治疗MSLN阳性晚期恶性实体肿瘤患者的初步有效性;确定MSLN表达的阳性界值;评价UCMYM802注射液在人体内的免疫应答过程及其影响因素。
[Translation] Primary objectives: To evaluate the safety and tolerability of UCMYM802 injection in the treatment of patients with MSLN-positive advanced malignant solid tumors; to determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of UCMYM802 injection in the treatment of patients with MSLN-positive advanced malignant solid tumors.
Secondary objectives: To evaluate the pharmacokinetic characteristics of UCMYM802 injection in subjects; to evaluate the pharmacodynamic characteristics of UCMYM802 injection in subjects; to evaluate the immunogenicity of UCMYM802 injection; to evaluate the preliminary effectiveness of UCMYM802 injection in the treatment of patients with MSLN-positive advanced malignant solid tumors; to determine the positive cutoff value of MSLN expression; to evaluate the immune response process of UCMYM802 injection in humans and its influencing factors.