[Translation] An open, multicenter, Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of ASKC202 tablets or ASK120067 tablets in patients with advanced solid tumors
主要目的
评价ASKC202片单、多次给药在晚期实体瘤患者中的安全性和耐受性, 确定 ASKC202片的剂量限制性毒性(DLT)和最大耐受剂量(MTD)。
评价ASKC202片联合ASK120067片在局部晚期或转移性非小细胞肺癌(NSCLC)患者中的安全性和耐受性,确定ASKC202 片联合 ASK120067片的剂量限制性毒性(DLT)和最大耐受剂量(MTD)。
次要目的
评价ASKC202 片在晚期实体瘤患者中的药代动力学特征;评价ASKC202片在晚期实体瘤患者中的初步抗肿瘤疗效,为确定后续临床研究给药方案提供依据。
评价ASKC202片联合ASK120067片在局部晚期或转移性NSCLC患者中的药代动力学特征;评价ASKC202片联合ASK120067片在局部晚期或转移性NSCLC患者中的初步抗肿瘤疗效,为确定后续临床研究给药方案提供依据。
[Translation] Main purpose
To evaluate the safety and tolerability of single and multiple administrations of ASKC202 tablets in patients with advanced solid tumors, and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of ASKC202 tablets.
To evaluate the safety and tolerability of ASKC202 tablets combined with ASK120067 tablets in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of ASKC202 tablets combined with ASK120067 tablets.
Secondary purpose
To evaluate the pharmacokinetic characteristics of ASKC202 tablets in patients with advanced solid tumors; to evaluate the preliminary anti-tumor efficacy of ASKC202 tablets in patients with advanced solid tumors, and to provide a basis for determining the dosing regimen for subsequent clinical studies.
To evaluate the pharmacokinetic characteristics of ASKC202 tablets combined with ASK120067 tablets in patients with locally advanced or metastatic NSCLC; to evaluate the preliminary anti-tumor efficacy of ASKC202 tablets combined with ASK120067 tablets in patients with locally advanced or metastatic NSCLC, and to provide a basis for determining the dosing regimen for subsequent clinical studies.