[Translation] A phase I clinical trial evaluating the tolerability and pharmacokinetics of TQB2223 injection combined with pembrolizumab in subjects with advanced malignant tumors
主要目的:
第一阶段:评估TQB2223注射液联合派安普利单抗在晚期恶性肿瘤受试者中的安全性和耐受性。
第二阶段:评估 TQB2223 注射液联合派安普利单抗在晚期恶性肿瘤受试者中 的初步疗效。
次要目的:
第一阶段:评估TQB2223注射液联合派安普利单抗在晚期恶性肿瘤受试中的药代动力学(PK)特征、受体占位情况、免疫原性特征。
第二阶段:评估 TQB2223 注射液联合派安普利单抗在晚期恶性肿瘤受试者中 的安全性和免疫原性特征。
探索性目的: 与疗效、作用机制、安全性和/或病理机制相关的生物标志物。
[Translation] main purpose:
Phase I: To evaluate the safety and tolerability of TQB2223 injection combined with pembrolizumab in subjects with advanced malignant tumors.
Phase II: To evaluate the preliminary efficacy of TQB2223 injection combined with pembrolizumab in subjects with advanced malignant tumors.
Secondary purpose:
Phase 1: To evaluate the pharmacokinetic (PK) characteristics, receptor occupancy, and immunogenicity characteristics of TQB2223 injection combined with pembrolizumab in advanced malignant tumor trials.
Phase II: To evaluate the safety and immunogenicity characteristics of TQB2223 injection combined with pembrolizumab in subjects with advanced malignant tumors.
Exploratory purposes: Biomarkers associated with efficacy, mechanism of action, safety, and/or pathology.