[Translation] An open, multicenter Phase I clinical study of the safety, tolerability, pharmacokinetics and efficacy of CVL006 injection in patients with advanced solid tumors
主要研究目的 :评价CVL006单药在晚期实体瘤患者中的安全性和耐受性;观察CVL006单药在晚期实体瘤中的剂量限制性毒性(DLT),评估最大耐受剂量(MTD)及推荐的II期临床研究的使用剂量(RP2D)。
次要研究目的:观察CVL006注射液单药在晚期实体瘤患者中的药代动力学(PK)特征;初步评价CVL006单药在晚期实体瘤患者中的有效性(包括客观缓解率[ORR]、肿瘤缓解持续时间[DoR]、疾病控制率[DCR]、最佳反应率[BOR]、无进展生存期[PFS])。(根据RECIST1.1标准);评价CVL006的免疫原性。
[Translation] Main study objectives: To evaluate the safety and tolerability of CVL006 monotherapy in patients with advanced solid tumors; To observe the dose-limiting toxicity (DLT) of CVL006 monotherapy in advanced solid tumors, and to evaluate the maximum tolerated dose (MTD) and the recommended dose for Phase II clinical studies (RP2D).
Secondary study objectives: To observe the pharmacokinetic (PK) characteristics of CVL006 injection monotherapy in patients with advanced solid tumors; To preliminarily evaluate the effectiveness of CVL006 monotherapy in patients with advanced solid tumors (including objective response rate [ORR], duration of tumor response [DoR], disease control rate [DCR], best response rate [BOR], progression-free survival [PFS]). (According to RECIST1.1 criteria); To evaluate the immunogenicity of CVL006.