[Translation] An open-label, multicenter, first-in-human, dose-escalation and expansion Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of DXC005 in patients with advanced solid tumors
评价DXC005在晚期实体瘤患者中的安全性和耐受性,确定DXC005的最大耐受剂量(MTD)和剂量限制性毒性(DLT),确定Ⅱ期临床试验推荐剂量(RP2D)。评价DXC005在晚期实体瘤患者体内的药代动力学(PK)特征。评价DXC005在晚期实体瘤患者体内产生的免疫原性、抗肿瘤活性。探讨患者肿瘤组织中靶点表达与治疗效果的相关性。探讨患者血液中肿瘤标志物CA242与治疗效果的相关性。
[Translation] Evaluate the safety and tolerability of DXC005 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of DXC005, and determine the recommended dose (RP2D) for Phase II clinical trials. Evaluate the pharmacokinetic (PK) characteristics of DXC005 in patients with advanced solid tumors. Evaluate the immunogenicity and anti-tumor activity of DXC005 in patients with advanced solid tumors. Explore the correlation between target expression in patient tumor tissues and treatment efficacy. Explore the correlation between tumor marker CA242 in patient blood and treatment efficacy.