[Translation] An open-label, multicenter, dose-escalation and cohort expansion Phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of IBR822 in patients with advanced solid tumors
Ⅰ期剂量递增阶段:评价IBR822的安全性和耐受性,确定IBR822的最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。次要目的:研究者根据实体肿瘤临床疗效评价标准及免疫相关的实体肿瘤临床疗效评价标准初步评价不同剂量IBR822在晚期实体瘤患者中的抗肿瘤疗效;描述IBR822细胞药代动力学(PK)特征;评估IBR822细胞注射液的免疫原性。回顾性分析肿瘤抗原Trop2表达情况和疗效的相关性。
Ⅱa期队列扩展阶段:主要目的:进一步评估IBR822在确定的RP2D下治疗Trop2阳性晚期实体瘤患者的安全性和耐受性,确定IBR822的后期推荐剂量;在已知Trop2表达阳性的研究人群中,由研究者根据RECIST v1.1及iRECIST标准评估的IBR822的抗肿瘤疗效。次要目的:分析肿瘤抗原Trop2表达情况和疗效的相关性。评估IBR822在Trop2阳性晚期实体瘤患者体内的药代动力学(PK)特征和评估IBR822在Trop2阳性晚期实体瘤患者中的免疫原性。
[Translation] Phase I dose escalation phase: evaluate the safety and tolerability of IBR822, determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D) of IBR822. Secondary purpose: researchers preliminarily evaluate the anti-tumor efficacy of different doses of IBR822 in patients with advanced solid tumors according to the solid tumor clinical efficacy evaluation criteria and immune-related solid tumor clinical efficacy evaluation criteria; describe the pharmacokinetic (PK) characteristics of IBR822 cells; evaluate the immunogenicity of IBR822 cell injection. Retrospective analysis of the correlation between tumor antigen Trop2 expression and efficacy.
Phase IIa cohort expansion phase: primary purpose: further evaluate the safety and tolerability of IBR822 in the treatment of patients with Trop2-positive advanced solid tumors under the determined RP2D, and determine the later recommended dose of IBR822; in the study population with known Trop2 expression, the anti-tumor efficacy of IBR822 evaluated by researchers according to RECIST v1.1 and iRECIST standards. Secondary purpose: analyze the correlation between tumor antigen Trop2 expression and efficacy. To evaluate the pharmacokinetic (PK) characteristics of IBR822 in patients with Trop2-positive advanced solid tumors and to evaluate the immunogenicity of IBR822 in patients with Trop2-positive advanced solid tumors.