[Translation] A first-in-human, open-label, Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SWA1211 tablets in patients with advanced solid tumors
评估 SWA1211 在晚期实体瘤患者中的安全性和耐受性;确定 SWA1211 的剂量限制性毒性(DLT)、最大耐受剂量(MTD)或最大给药剂量(MAD)、和/或 II 期推荐剂量(RP2D)。
评估 SWA1211 的药代动力学(PK)特征; 评估 SWA1211 的初步抗肿瘤疗效;
对血液中 SWA1211 的代谢产物进行鉴定和定量分析(如适用);探索 SWA1211 对按心率校正的 QT 间期(QTcF,经 Fridericia 公式校正)的影响;探索 SWA1211 的药效学(PD)和其他生物标志物特征。
[Translation] Evaluate the safety and tolerability of SWA1211 in patients with advanced solid tumors; determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD), and/or Phase II recommended dose (RP2D) of SWA1211.
Evaluate the pharmacokinetic (PK) characteristics of SWA1211; Evaluate the preliminary anti-tumor efficacy of SWA1211;
Identify and quantify the metabolites of SWA1211 in the blood (if applicable); explore the effect of SWA1211 on the QT interval corrected for heart rate (QTcF, corrected by Fridericia's formula); explore the pharmacodynamics (PD) and other biomarker characteristics of SWA1211.