[Translation] A multicenter, single-arm, open-label Phase Ia/Ib clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of oral GH56 capsules in subjects with advanced solid tumors with MTAP deletion
剂量递增研究(Ia期):
主要目的:评价GH56胶囊在MTAP缺失的晚期实体瘤患者中的安全性和耐受性、扩展期推荐剂量(RDEs)和/或最大耐受剂量(MTD)。
次要目的:评价GH56胶囊在MTAP缺失的晚期实体瘤患者中的药代动力学(PK)特征、初步抗肿瘤疗效和血药浓度对QT/QTc间期的影响。
剂量扩展研究(Ib期):
主要目的:评价GH56胶囊在MTAP缺失晚期实体瘤患者初步抗肿瘤活性、安全性和耐受性及确定GH56的II期临床研究推荐剂量RP2D。
次要目的:评价GH56胶囊在MTAP缺失的晚期实体瘤患者中的药代动力学(PK)特征和其他抗肿瘤疗效。
[Translation] Dose escalation study (Phase Ia):
Primary objective: To evaluate the safety and tolerability, recommended doses (RDEs) for the extension phase and/or the maximum tolerated dose (MTD) of GH56 capsules in patients with advanced solid tumors with MTAP deletion.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics, preliminary anti-tumor efficacy and the effect of blood drug concentration on QT/QTc interval of GH56 capsules in patients with advanced solid tumors with MTAP deletion.
Dose expansion study (Phase Ib):
Primary objective: To evaluate the preliminary anti-tumor activity, safety and tolerability of GH56 capsules in patients with advanced solid tumors with MTAP deletion and to determine the recommended dose RP2D for the Phase II clinical study of GH56.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics and other anti-tumor efficacy of GH56 capsules in patients with advanced solid tumors with MTAP deletion.