[Translation] Phase I/II clinical study on the safety, tolerability and preliminary efficacy of C019199 combined with sintilimab in the treatment of patients with advanced malignant solid tumors
主要目的:
I期研究:
评估C019199联合信迪利单抗在治疗晚期实体瘤患者的安全性和耐受性,确定最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。
II期研究:
评估C019199联合信迪利单抗治疗晚期实体瘤患者的客观缓解率(ORR)[免疫相关实体瘤疗效评价标准irRECIST]和无进展生存期(PFS)。
次要目的:
I期研究:
1.评价C019199联合信迪利单抗在晚期实体瘤患者中的药代动力学(PK)。
2.评估C019199联合信迪利单抗治疗晚期实体瘤患者的初步疗效:客观缓解率(ORR)、缓解持续时间(DOR)、无进展生存期(PFS)、总生存期(OS)、疾病控制率(DCR)。
II期研究:
1.评价C019199联合信迪利单抗的安全性。
2.评价C019199联合信迪利单抗治疗晚期实体瘤患者的疗效:缓解持续时间(DOR)、总生存期(OS)、疾病控制率(DCR)。
[Translation] Main purpose:
Phase I study:
Evaluate the safety and tolerability of C019199 combined with sintilimab in the treatment of patients with advanced solid tumors, and determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).
Phase II study:
Evaluate the objective response rate (ORR) [irRECIST for immune-related solid tumor efficacy evaluation criteria] and progression-free survival (PFS) of C019199 combined with sintilimab in the treatment of patients with advanced solid tumors.
Secondary purpose:
Phase I study:
1. Evaluate the pharmacokinetics (PK) of C019199 combined with sintilimab in patients with advanced solid tumors.
2. Evaluate the preliminary efficacy of C019199 combined with sintilimab in the treatment of patients with advanced solid tumors: objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and disease control rate (DCR).
Phase II study:
1. Evaluate the safety of C019199 combined with sintilimab.
2. Evaluate the efficacy of C019199 combined with sintilimab in the treatment of patients with advanced solid tumors: duration of response (DOR), overall survival (OS), and disease control rate (DCR).