[Translation] A Phase I/IIa study to evaluate the safety, tolerability, pharmacokinetics and efficacy of THZ0104 in patients with locally advanced or metastatic solid tumors
I期(单药治疗剂量递增研究)
主要目的:
评价THZ0104的安全性和耐受性;
确定THZ0104的最大耐受剂量(MTD)和/或Ⅱ期推荐剂量(RP2D)。
次要目的:
评价THZ0104的药代动力学(PK)特征、免疫原性;
根据RECIST v1.1初步评价THZ0104的抗肿瘤疗效。 IIa期(单药治疗队列扩展研究)
主要目的:
根据RECIST v1.1评价THZ0104的抗肿瘤疗效。
次要目的:
进一步评价THZ0104的安全性和耐受性、PK特征、免疫原性
[Translation] Phase I (monotherapy dose escalation study)
Primary objectives:
Evaluate the safety and tolerability of THZ0104;
Determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D) of THZ0104.
Secondary objectives:
Evaluate the pharmacokinetic (PK) characteristics and immunogenicity of THZ0104;
Preliminary evaluation of the anti-tumor efficacy of THZ0104 according to RECIST v1.1. Phase IIa (monotherapy cohort expansion study)
Primary objectives:
Evaluate the anti-tumor efficacy of THZ0104 according to RECIST v1.1.
Secondary objectives:
Further evaluate the safety and tolerability, PK characteristics, and immunogenicity of THZ0104