[Translation] Phase I clinical evaluation of dose escalation and expansion of RMX1002 alone and in combination with PD-1 monoclonal antibody in patients with advanced solid tumors on pharmacokinetics, tolerability, and preliminary efficacy evaluation
主要目的:RMX1002单药、RMX1002联合PD-1单抗治疗晚期实体瘤患者的安全性及耐受性,确定MTD和/或后期推荐剂量; 次要目的:RMX1002、RMX1002联合PD-1单抗在晚期实体瘤患者体内的PK特征、初步疗效、安全性及耐受性; 探索性: PD指标与RMX1002、RMX1002联合PD-1单抗疗效的潜在关系;生物标志物与RMX1002联合PD-1单抗治疗方案预后的相关性
[Translation] Main purpose: The safety and tolerability of RMX1002 monotherapy, RMX1002 combined with PD-1 monoclonal antibody in the treatment of patients with advanced solid tumors, and to determine the MTD and/or the recommended dose in the later stage; Secondary objectives: RMX1002, RMX1002 combined with PD-1 monoclonal antibody in the PK characteristics, preliminary efficacy, safety and tolerability in patients with advanced solid tumors; Exploratory: Potential relationship between PD indicators and the efficacy of RMX1002, RMX1002 combined with PD-1 mAb; biomarkers and RMX1002 combined with PD-1 mAb Correlation of treatment regimens with prognosis