[Translation] A multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor efficacy of RNK08954 in Chinese subjects with advanced solid tumors with KRAS G12D mutations
确定RNK08954在KRAS G12D突变晚期实体瘤受试者中的推荐扩展剂量(RDE)和最大耐受剂量(MTD),评估RNK08954在KRAS G12D突变晚期实体瘤受试者中的安全性和耐受性,药代动力学(PK)特征,抗肿瘤活性的初步证据。进一步评估RDE剂量治疗KRAS G12D突变晚期实体瘤受试者的安全性和耐受性、主要和次要抗肿瘤疗效终点,药代动力学(PK)特征 。探索安全性和/或疗效终点与PK/PD的关系,评价PoP PK参数,探索与RNK08954相关的生物标志物,并探索生物标志物的变化与疗效的关系。
[Translation] To determine the recommended extended dose (RDE) and maximum tolerated dose (MTD) of RNK08954 in subjects with KRAS G12D mutant advanced solid tumors, and to evaluate the safety and tolerability, pharmacokinetic (PK) characteristics, and preliminary evidence of antitumor activity of RNK08954 in subjects with KRAS G12D mutant advanced solid tumors. To further evaluate the safety and tolerability, primary and secondary antitumor efficacy endpoints, and pharmacokinetic (PK) characteristics of RDE dose-treated subjects with KRAS G12D mutant advanced solid tumors. To explore the relationship between safety and/or efficacy endpoints and PK/PD, evaluate PoP PK parameters, explore biomarkers associated with RNK08954, and explore the relationship between changes in biomarkers and efficacy.