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MechanismPORCN inhibitors |
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Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
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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).
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.
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