[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of GH2616 tablets in subjects with advanced solid tumors
剂量递增研究(Ia) 主要目的:1、评估GH2616片在具有TP53功能性缺失突变晚期实体瘤中的安全性、耐受性和剂量限制性毒性(DLTs)。2、确定GH2616片治疗晚期实体瘤的最大耐受剂量(MTD)和/或扩展期推荐剂量(RDEs)。
剂量扩展研究(Ib) 主要目的:1、评估GH2616片在具有TP53功能性缺失突变和WGD特征的晚期实体瘤受试者中的初步抗肿瘤活性和安全性。2、确定GH2616片II期临床研究推荐剂量(RP2D)。
[Translation] Dose escalation study (Ia) Main objectives: 1. Evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of GH2616 tablets in advanced solid tumors with TP53 functional loss mutations. 2. Determine the maximum tolerated dose (MTD) and/or recommended doses (RDEs) for the extension period of GH2616 tablets for the treatment of advanced solid tumors.
Dose expansion study (Ib) Main objectives: 1. Evaluate the preliminary anti-tumor activity and safety of GH2616 tablets in subjects with advanced solid tumors with TP53 functional loss mutations and WGD characteristics. 2. Determine the recommended dose (RP2D) for the Phase II clinical study of GH2616 tablets.