[Translation] An open-label, international, multicenter, first-in-human, dose-escalation, and expanded Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of DXC004A for injection in patients with advanced solid tumors
评价DXC004A在晚期实体瘤患者中的安全性和耐受性;确定DXC004A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);评价药代动力学(PK)特征及免疫原性;初步评价 DXC004A 治疗晚期实体瘤患者的有效性。
[Translation] To evaluate the safety and tolerability of DXC004A in patients with advanced solid tumors; to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of DXC004A; to determine the recommended dose (RP2D) for Phase II clinical trials; to evaluate the pharmacokinetic (PK) characteristics and immunogenicity; and to preliminarily evaluate the effectiveness of DXC004A in the treatment of patients with advanced solid tumors.