[Translation] Phase I/II clinical study on the tolerability, safety, efficacy and pharmacokinetics of ZG2001 tosylate tablets in patients with advanced solid tumors carrying KRAS mutations, with dose escalation and multi-cohort expansion
第一阶段-单药剂量递增及食物对ZG2001药物代谢影响研究阶段
剂量递增部分,主要目的:考察ZG2001单药在经标准治疗进展、不耐受或无标准治疗的携带KRAS突变的晚期实体瘤患者中的安全性和耐受性,并考察在设定剂量组中可能出现的剂量限制性毒性(DLT)和最大耐受剂量(MTD)。
食物对ZG2001药物代谢影响研究部分,主要目的:研究推荐剂量下食物对ZG2001代谢的影响。
第二阶段-ZG2001单药扩展研究阶段
主要目的:考察ZG2001(RP2D)单药治疗经至少一线标准治疗失败的携带KRAS突变的晚期实体瘤(如非小细胞肺癌、结直肠癌、胰腺癌等)患者中的有效性。
探索性目的:分析潜在生物标志物(如SOS1、PTPN11、NF1)与疗效的关系。
[Translation] Phase I - Single-drug dose escalation and food effect on ZG2001 drug metabolism
Dose escalation part, main purpose: to investigate the safety and tolerability of ZG2001 monotherapy in patients with advanced solid tumors carrying KRAS mutations who have progressed, are intolerant or have no standard treatment, and to investigate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) that may occur in the set dose group.
Study of food effect on ZG2001 drug metabolism, main purpose: to study the effect of food on ZG2001 metabolism at the recommended dose.
Phase II - ZG2001 monotherapy expansion study phase
Main purpose: to investigate the efficacy of ZG2001 (RP2D) monotherapy in patients with advanced solid tumors carrying KRAS mutations (such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, etc.) who have failed at least one line of standard treatment.
Exploratory purpose: to analyze the relationship between potential biomarkers (such as SOS1, PTPN11, NF1) and efficacy.