[Translation] An open-label, multicenter, Phase I/II study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE-86225106 as a monotherapy in patients with advanced solid tumors
I期阶段探究ACE-86225106的安全性和耐受性并确定ACE-86225106的RP2D和/或MTD;探究初步疗效并评估ACE-86225106的PK/PD。 剂量扩展阶段:研究初步疗效;进一步探究ACE-86225106的安全性和耐受性; 使用其他疗效参数探究初步疗效;进一步评估ACE-86225106的PK/PD;评估食物对ACE-86225106 PK特征的影响。
[Translation] Phase I: To explore the safety and tolerability of ACE-86225106 and determine the RP2D and/or MTD of ACE-86225106; to explore the preliminary efficacy and evaluate the PK/PD of ACE-86225106. Dose expansion phase: To study the preliminary efficacy; to further explore the safety and tolerability of ACE-86225106; to explore the preliminary efficacy using other efficacy parameters; to further evaluate the PK/PD of ACE-86225106; to evaluate the effect of food on the PK characteristics of ACE-86225106.