[Translation] A Phase I clinical study of the safety, tolerability, pharmacokinetics and efficacy of HS-20110 in patients with advanced solid tumors
Ia期:
主要研究目的:评价HS-20110在晚期实体瘤受试者中的安全性和耐受性
次要研究目的:评价HS-20110在晚期实体瘤受试者中的有效性;评价HS-20110在晚期实体瘤受试者中的药代动力学(PK)特征;评价HS-20110在晚期实体瘤受试者中的免疫原性
Ib期:
主要研究目的:评价HS-20110在晚期实体瘤受试者中的有效性;确认HS-20110的II期推荐剂量(RP2D)
次要研究目的:评价HS-20110在晚期实体瘤受试者中的其他安全性指标;评价HS-20110在晚期实体瘤受试者中的其他有效性指标;评价HS-20110在晚期实体瘤受试者中的PK特征;评价HS-20110在晚期实体瘤受试者中的免疫原性
[Translation] Phase Ia:
Main study objective: To evaluate the safety and tolerability of HS-20110 in subjects with advanced solid tumors
Secondary study objectives: To evaluate the efficacy of HS-20110 in subjects with advanced solid tumors; To evaluate the pharmacokinetic (PK) characteristics of HS-20110 in subjects with advanced solid tumors; To evaluate the immunogenicity of HS-20110 in subjects with advanced solid tumors
Phase Ib:
Main study objective: To evaluate the efficacy of HS-20110 in subjects with advanced solid tumors; To confirm the Phase II recommended dose (RP2D) of HS-20110
Secondary study objectives: To evaluate other safety indicators of HS-20110 in subjects with advanced solid tumors; To evaluate other efficacy indicators of HS-20110 in subjects with advanced solid tumors; To evaluate the PK characteristics of HS-20110 in subjects with advanced solid tumors; To evaluate the immunogenicity of HS-20110 in subjects with advanced solid tumors