[Translation] A Phase I clinical study of the safety, tolerability, pharmacokinetics and efficacy of HS-10386 in patients with advanced solid tumors
Ia期:主要目的:评价 HS-10386 在晚期实体瘤患者中的安全性和耐受性 次要目的:评价 HS-10386 在晚期实体瘤患者中的其他安全性指标;评价 HS-10386 在晚期实体瘤患者中的 PK 特征;评价 HS-10386 在晚期实体瘤患者中的有效性 探索性目的:评价 HS-10386 在晚期实体瘤患者治疗前后的生物标志物,包括细胞因子如 IFN-γ、CXCL9、CXCL10 等; 可溶性 PD-L1; 以及外周血免疫细胞亚型和功能的变化与药物剂量和药效的关系;Ib期:主要目的:评价 HS-10386 在晚期实体瘤患者中的有效性 次要目的:评价 HS-10386 在晚期实体瘤患者中的其他有效性指标;评价 HS-10386 在晚期实体瘤患者中的安全性;评价 HS-10386 在晚期实体瘤患者中的 PK 特征;评价肿瘤组织 PD-L1 表达水平与 HS-10386 疗效的关系 探索性目的:评价 HS-10386 在晚期实体瘤患者中根据 iRECIST 标准评估的有效性;评价 HS-10386 在晚期实体瘤患者治疗前后生物标志物变化与药物剂量和药效的相关性
[Translation] Phase Ia: Primary objective: To evaluate the safety and tolerability of HS-10386 in patients with advanced solid tumors Secondary objectives: To evaluate other safety indicators of HS-10386 in patients with advanced solid tumors; To evaluate the PK characteristics of HS-10386 in patients with advanced solid tumors; To evaluate the effectiveness of HS-10386 in patients with advanced solid tumors Exploratory objectives: To evaluate the biomarkers of HS-10386 before and after treatment in patients with advanced solid tumors, including cytokines such as IFN-γ, CXCL9, CXCL10, etc.; soluble PD-L1; and the relationship between changes in peripheral blood immune cell subtypes and functions and drug dose and efficacy; Phase Ib: Primary objective: To evaluate the effectiveness of HS-10386 in patients with advanced solid tumors Secondary objectives: To evaluate other effectiveness indicators of HS-10386 in patients with advanced solid tumors; To evaluate the safety of HS-10386 in patients with advanced solid tumors; To evaluate the PK characteristics of HS-10386 in patients with advanced solid tumors; To evaluate tumor tissue Relationship between PD-L1 expression level and HS-10386 efficacy Exploratory purpose: To evaluate the efficacy of HS-10386 in patients with advanced solid tumors according to iRECIST criteria; To evaluate the correlation between changes in biomarkers and drug dose and efficacy before and after HS-10386 treatment in patients with advanced solid tumors