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Clinical Trials associated with TQB2029Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma
This is a study to evaluate the maximum tolerated dose (MTD), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with multiple myeloma. The study is divided into Phase Ia and Ib, Phase Ia: dose escalation phase, to evaluate the safety and tolerability of TQB2029 for injection, and determining DLT and MTD; Phase Ib: Dose extension phase, to evaluate the effectiveness of TQB2029 for injection in subjects with multiple myeloma.
评估注射用TQB2029在多发性骨髓瘤受试者中耐受性和药代动力学的I期临床研究
[Translation] A Phase I clinical study to evaluate the tolerability and pharmacokinetics of TQB2029 for injection in subjects with multiple myeloma
主要目的:1.评估注射用TQB2029在多发性骨髓瘤受试者中的安全性和耐受性;2.评估注射用TQB2029在多发性骨髓瘤受试者中的有效性。
次要目的:1.评估注射用TQB2029在多发性骨髓瘤受试者中的药代动力学(PK)特征、药效动力学(PD)特征、免疫原性及初步有效性;2.评估注射用TQB2029在多发性骨髓瘤受试者中的其他有效性指标、安全性、PK、PD及免疫原性特征。
[Translation] Primary objectives: 1. To evaluate the safety and tolerability of TQB2029 for injection in subjects with multiple myeloma; 2. To evaluate the effectiveness of TQB2029 for injection in subjects with multiple myeloma.
Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity and preliminary effectiveness of TQB2029 for injection in subjects with multiple myeloma; 2. To evaluate other effectiveness indicators, safety, PK, PD and immunogenicity characteristics of TQB2029 for injection in subjects with multiple myeloma.
100 Clinical Results associated with TQB2029
100 Translational Medicine associated with TQB2029
100 Patents (Medical) associated with TQB2029
100 Deals associated with TQB2029