[Translation] Phase I/II clinical study of the safety, tolerability, pharmacokinetics and efficacy of HS-10375 in patients with advanced non-small cell lung cancer
主要目的:在剂量递增期,通过DLT、MTD和其他指标评价HS-10375在局部晚期或转移性NSCLC受试者中的安全性和耐受性。在剂量扩展期,根据研究者评估,通过ORR来确定HS-10375在携带EGFR C797S顺式三突变(EGFR敏感突变<19外显子缺失或L858R>合并T790M突变和顺式C797S突变)和EGFR C797S双突变(EGFR敏感突变<19外显子缺失或L858R>合并C797S突变)的局部晚期或转移性NSCLC受试者中的疗效。在剂量延伸期,根据IRC评估,通过ORR来评价HS-10375在携带EGFR C797S顺式三突变的局部晚期或转移性NSCLC受试者中的疗效。
[Translation] Primary Objective: In the dose escalation phase, the safety and tolerability of HS-10375 in subjects with locally advanced or metastatic NSCLC will be evaluated by DLT, MTD, and other indicators. In the dose expansion phase, the efficacy of HS-10375 in subjects with locally advanced or metastatic NSCLC carrying EGFR C797S cis triple mutations (EGFR sensitive mutations < exon 19 deletion or L858R> combined with T790M mutation and cis C797S mutation) and EGFR C797S double mutations (EGFR sensitive mutations < exon 19 deletion or L858R> combined with C797S mutation) will be determined by ORR based on investigator assessment. In the dose extension phase, the efficacy of HS-10375 in subjects with locally advanced or metastatic NSCLC carrying EGFR C797S cis triple mutations will be evaluated by ORR based on IRC assessment.