[Translation] A Phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of DN022150 for injection in patients with advanced solid tumors carrying KRAS G12D mutations
主要目的:
评价注射用DN022150在携带KRAS G12D突变的晚期实体瘤受试者中的安全性和耐受性;探索注射用DN022150的最大耐受剂量(MTD)及确定II期临床研究推荐剂量(RP2D)。
评估注射用DN022150在携带KRAS G12D突变的晚期实体瘤受试者中的有效性。
次要目的:
评估注射用DN022150在携带KRAS G12D突变的晚期实体瘤受试者中的药代动力学(Pharmacokinetics,PK)特征。
探索性目的:
探索KRAS G12D的突变频率(VAF)与临床疗效之间的相关性;
评价注射用DN022150对携带KRAS G12D突变的晚期实体瘤受试者QT/QTc间期的影响;
探索共突变基因与临床疗效的关系和耐药机制。
探索药物暴露-效应关系。
[Translation] Primary objective:
Evaluate the safety and tolerability of DN022150 for injection in subjects with advanced solid tumors carrying KRAS G12D mutations; explore the maximum tolerated dose (MTD) of DN022150 for injection and determine the recommended dose (RP2D) for phase II clinical studies.
Evaluate the efficacy of DN022150 for injection in subjects with advanced solid tumors carrying KRAS G12D mutations.
Secondary objective:
Evaluate the pharmacokinetic (PK) characteristics of DN022150 for injection in subjects with advanced solid tumors carrying KRAS G12D mutations.
Exploratory objective:
Explore the correlation between the mutation frequency (VAF) of KRAS G12D and clinical efficacy;
Evaluate the effect of DN022150 for injection on the QT/QTc interval of subjects with advanced solid tumors carrying KRAS G12D mutations;
Explore the relationship between co-mutated genes and clinical efficacy and the mechanism of drug resistance.
Explore the drug exposure-effect relationship.