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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
甲苯磺酸ZG2001片在携带KRAS 突变的晚期实体瘤患者中的耐受性、安全性、有效性和药代动力学剂量递增和多队列扩展的Ⅰ/Ⅱ期临床研究
[Translation] Tolerability, Safety, Efficacy and Pharmacokinetics of ZG2001 Toluenesulfonic Acid Tablets in Patients with Advanced Solid Tumors Carrying KRAS Mutations: A Phase I/II Clinical Study of 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] The first phase - single drug dose escalation and the effect of food on ZG2001 drug metabolism research phase
Dose escalation part, the main purpose: to investigate the safety and tolerability of ZG2001 monotherapy in patients with advanced solid tumors carrying KRAS mutations who have progressed through standard treatment, who are intolerant or have no standard treatment, and to investigate the safety and tolerability of ZG2001 in the set dose group. Possible dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
The part of research on the effect of food on ZG2001 drug metabolism, the main purpose: to study the effect of food on the metabolism of ZG2001 at the recommended dose.
The second phase - ZG2001 monotherapy expansion research phase
Main purpose: To investigate the effectiveness of ZG2001 (RP2D) monotherapy in patients with advanced solid tumors (such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, etc.) carrying KRAS mutations who have failed at least one-line standard treatment.
Exploratory purpose: To analyze the relationship between potential biomarkers (such as SOS1, PTPN11, NF1) and efficacy.
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