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MechanismPORCN inhibitors |
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Drug Highest PhasePhase 1 |
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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] An open-label dose-escalation study of naphthyridine phosphate (CGX1321) in advanced gastrointestinal cancer (Phase I)
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] Main objective: To evaluate the safety and tolerability of oral CGX1321 in patients with advanced gastrointestinal cancers (including gastrointestinal cancers with Rspo2, Rspo3 and RNF43 gene mutations); to determine dose-limiting toxicity (DLT) and maximum tolerability Dose (MTD) and/or recommended dose for Phase 2 studies (RP2D); further evaluation in subjects with histologically diagnosed GI tumors with confirmed alterations in genes upstream of the WNT signaling pathway (eg, Rspo2, Rspo3, or RNF43) Safety and tolerability of CGX1321 at MTD and/or RP2D doses (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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