|
MechanismPORCN inhibitors |
|
|
|
|
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.
磷酸源生萘啶(CGX1321)治疗晚期胃肠道癌症的开放性剂量递增研究(I期)
[Translation] Phase I open-label, dose-escalation study of CGX1321 in the treatment of advanced gastrointestinal cancer
主要目的:评价口服CGX1321在晚期胃肠道癌症(包括伴有Rspo2、Rspo3和RNF43基因突变的胃肠道癌症)患者的安全性和耐受性;确定剂量限制性毒性(DLT)及最大耐受剂量(MTD)和/或临床2期研究推荐剂量(RP2D);进一步评价在证实有WNT信号通路上游基因(例如,Rspo2、Rspo3或RNF43)改变的组织学诊断的GI肿瘤受试者中,在MTD和/或RP2D剂量下,CGX1321的安全性和耐受性(扩大研究阶段)。
[Translation] Primary objectives: To evaluate the safety and tolerability of oral CGX1321 in patients with advanced gastrointestinal cancer (including gastrointestinal cancer with Rspo2, Rspo3 and RNF43 gene mutations); to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) and/or the recommended dose (RP2D) for Phase 2 clinical studies; to further evaluate the safety and tolerability of CGX1321 at the MTD and/or RP2D doses in subjects with histologically diagnosed GI tumors with confirmed alterations in genes upstream of the WNT signaling pathway (e.g., Rspo2, Rspo3 or RNF43) (expansion study phase).
100 Clinical Results associated with Guangzhou Curegenix Ltd.
0 Patents (Medical) associated with Guangzhou Curegenix Ltd.
100 Deals associated with Guangzhou Curegenix Ltd.
100 Translational Medicine associated with Guangzhou Curegenix Ltd.