[Translation] A Phase Ia/Ib dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of GH2616 tablets in subjects with advanced solid tumors
剂量递增阶段(Ia期):评估GH2616片在晚期实体瘤中的安全性、耐受性和剂量限制性毒性(DLTs);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)。
剂量拓展阶段(Ib期):评估GH2616片在晚期实体瘤中的初步抗肿瘤活性和安全性;确定GH2616片II期临床研究推荐剂量(RP2D)。
[Translation] Dose escalation phase (Phase Ia): Evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of GH2616 tablets in advanced solid tumors; determine the maximum tolerated dose (MTD) and/or recommended doses for extension (RDEs) of GH2616 tablets in the treatment of advanced solid tumors.
Dose expansion phase (Phase Ib): Evaluate the preliminary anti-tumor activity and safety of GH2616 tablets in advanced solid tumors; determine the recommended dose (RP2D) of GH2616 tablets in Phase II clinical studies.