[Translation] A first-in-human (FIH), open-label, dose-escalation and expansion Phase I/II clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of LM-168, either alone or in combination with toripalimab, in patients with advanced solid tumors (currently only Phase I monotherapy trials are underway)
I 期剂量递增阶段的主要目的为:评估 LM-168 单药或与特瑞普利单抗联合治疗方案在晚期实体瘤受试者的安全性和耐受性,确定最大耐受剂量( MTD)和探索 II 期 推荐剂量( RP2D)。同时评估 LM-168 的药代动力学 (PK) 特性、免疫原性,评估 LM-168 单药或与特瑞普利单抗联合治疗方案在晚期实体瘤患者的初步抗肿瘤活性。
II 期剂量扩展阶段的主要目的为评估 LM-168 单药或与特瑞普利单抗联合治疗方案在晚期实体瘤患者的初步抗肿瘤活性,同时评估 LM-168 单药或与特瑞普利单抗联合治疗方案在晚期实体瘤患者的安全性和耐受性;评估 LM-168 的药代动力学( PK)特征和免疫原性。
[Translation] The primary objectives of the Phase I dose-escalation phase are to evaluate the safety and tolerability of LM-168, either alone or in combination with toripalimab, in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), and explore the recommended Phase II dose (RP2D). The pharmacokinetic (PK) properties and immunogenicity of LM-168 will also be evaluated, as will the preliminary anti-tumor activity of LM-168, either alone or in combination with toripalimab, in patients with advanced solid tumors.
The primary objectives of the Phase II dose-expansion phase are to evaluate the preliminary anti-tumor activity of LM-168, either alone or in combination with toripalimab, in patients with advanced solid tumors, as well as the safety and tolerability of LM-168, either alone or in combination with toripalimab, and to assess the pharmacokinetic (PK) properties and immunogenicity of LM-168.