[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant interleukin-21-anti-human serum albumin nanobody fusion protein (JS014) alone and in combination with toripalimab in patients with advanced tumors
主要目的: 评价 JS014 单药及联合特瑞普利单抗在晚期肿瘤患者中的安全性和耐受性; 确定JS014单药及联合特瑞普利单抗在晚期肿瘤患者中的最大耐受剂量(MTD) 和II期推荐剂量(RP2D)。
次要目的:
评价 JS014 单药及联合特瑞普利单抗在晚期肿瘤患者中的药代动力学(PK)特征; 评价 JS014 单药及联合特瑞普利单抗在晚期肿瘤患者中的免疫原性;
初步评价 JS014 单药及联合特瑞普利单抗治疗晚期肿瘤的有效性。
评价 JS014 单药及联合特瑞普利单抗的药效学特征;
探索性目的: 探索相关生物标志物与临床疗效的关系。
[Translation] Primary objective: To evaluate the safety and tolerability of JS014 alone and in combination with toripalimab in patients with advanced tumors; To determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of JS014 alone and in combination with toripalimab in patients with advanced tumors.
Secondary objectives:
To evaluate the pharmacokinetic (PK) characteristics of JS014 alone and in combination with toripalimab in patients with advanced tumors; To evaluate the immunogenicity of JS014 alone and in combination with toripalimab in patients with advanced tumors;
To preliminarily evaluate the effectiveness of JS014 alone and in combination with toripalimab in the treatment of advanced tumors.
To evaluate the pharmacodynamic characteristics of JS014 alone and in combination with toripalimab;
Exploratory objective: To explore the relationship between relevant biomarkers and clinical efficacy.