[Translation] A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of YK-029A tablets in patients with advanced non-small cell lung cancer (NSCLC)
评价YK-029A片的最大耐受剂量(MTD)、剂量限制性毒性(DLT),确定II期临床试验推荐的给药方案和剂量。研究YK-029A片药代动力学特征,分析药代动力学及其与药效(PK/PD)/毒性(PK/AE)之间的关系,检测代谢产物。评价YK-029A片治疗对经既往表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKI)治疗后T790M突变获得性耐药和疾病进展的晚期非小细胞肺癌患者的初步疗效。
[Translation] To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of YK-029A tablets, and determine the recommended dosing regimen and dose for Phase II clinical trials. To study the pharmacokinetic characteristics of YK-029A tablets, analyze the relationship between pharmacokinetics and pharmacodynamics (PK/PD)/toxicity (PK/AE), and detect metabolites. To evaluate the preliminary efficacy of YK-029A tablets in patients with advanced non-small cell lung cancer with acquired resistance and disease progression to T790M mutation after previous epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment.