[Translation] A Phase Ia/Ib clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetics of HDM2012 in subjects with advanced solid tumors
第一部分(剂量递增阶段,Ⅰa)主要目的:评价不同剂量下HDM2012在晚期实体瘤受试者中的安全性和耐受性。探索HDM2012在晚期实体瘤受试者中的最大耐受剂量(MTD),并确定推荐扩展剂量(RDE)。次要目的:评估HDM2012在晚期实体瘤受试者中的药代动力学(PK)特征。评估HDM2012在晚期实体瘤受试者中的免疫原性特征。评估HDM2012在晚期实体瘤受试者中的初步抗肿瘤活性。
第二部分(剂量扩展阶段,Ⅰb)主要目的:评估RDE剂量下HDM2012 在特定癌种中的初步抗肿瘤活性。评估RDE剂量下HDM2012的安全性和耐受性。确定HDM2012的Ⅱ期临床试验推荐剂量(RP2D)。次要目的:评估RDE剂量下HDM2012在特定癌种中的长期疗效。研究HDM2012治疗晚期实体瘤受试者中的PK特征。研究HDM2012治疗晚期实体瘤受试者中的免疫原性特征。
[Translation] Part I (dose escalation phase, Ia)Main objectives: To evaluate the safety and tolerability of HDM2012 at different doses in subjects with advanced solid tumors. To explore the maximum tolerated dose (MTD) of HDM2012 in subjects with advanced solid tumors and determine the recommended dose for expansion (RDE). Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of HDM2012 in subjects with advanced solid tumors. To evaluate the immunogenicity characteristics of HDM2012 in subjects with advanced solid tumors. To evaluate the preliminary anti-tumor activity of HDM2012 in subjects with advanced solid tumors.
Part II (dose expansion phase, Ib)Main objectives: To evaluate the preliminary anti-tumor activity of HDM2012 at the RDE dose in specific cancer types. To evaluate the safety and tolerability of HDM2012 at the RDE dose. To determine the recommended dose (RP2D) for Phase II clinical trials of HDM2012. Secondary objectives: To evaluate the long-term efficacy of HDM2012 at the RDE dose in specific cancer types. To study the PK characteristics of HDM2012 in subjects with advanced solid tumors. To investigate the immunogenicity profile of HDM2012 in subjects with advanced solid tumors.