[Translation] A phase I clinical study of the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of JS019, a recombinant fully human anti-CD39 monoclonal antibody, in patients with advanced solid tumors or lymphomas
评价JS019单药在晚期恶性实体瘤/淋巴瘤患者中的安全性和耐受性;
确定JS019单药的最大耐受剂量(MTD,如果可能)和II期临床研究推荐剂量(RP2D)
评价JS019单药在晚期恶性实体瘤/淋巴瘤患者中的药代动力学(PK)特征;
评价JS019单药在晚期恶性实体瘤/淋巴瘤患者中的免疫原性;
评价JS019单药在晚期恶性实体瘤/淋巴瘤患者体内的药效学特征;
初步评估JS019单药治疗晚期恶性实体瘤/淋巴瘤的有效性
探索相关生物标志物与疗效间的相关性
[Translation] Evaluate the safety and tolerability of JS019 monotherapy in patients with advanced malignant solid tumors/lymphomas;
Determine the maximum tolerated dose (MTD, if possible) and recommended dose (RP2D) of JS019 monotherapy for Phase II clinical studies
Evaluate the pharmacokinetic (PK) characteristics of JS019 monotherapy in patients with advanced malignant solid tumors/lymphomas;
Evaluate the immunogenicity of JS019 monotherapy in patients with advanced malignant solid tumors/lymphomas;
Evaluate the pharmacodynamic characteristics of JS019 monotherapy in patients with advanced malignant solid tumors/lymphomas;
Preliminary evaluation of the effectiveness of JS019 monotherapy in the treatment of advanced malignant solid tumors/lymphomas
Explore the correlation between relevant biomarkers and efficacy