[Translation] A Phase I/II clinical trial of the highly selective RET inhibitor HEC169096 tablets in the treatment of non-small cell lung cancer, thyroid cancer and other advanced solid tumors
I期:
主要目的:确定HEC169096的最大耐受剂量(MTD)/Ⅱ期推荐剂量(RP2D);
次要目的:评估HEC169096在晚期实体瘤受试者中安全性和耐受性;
观察HEC169096在晚期实体瘤受试者中的PK特征和药物代谢转化;
评估HEC169096在晚期实体瘤受试者中的疗效;
II期:
主要目的:评估HEC169096在RET融合NSCLC、RET突变MTC及其他RET改变晚期实体瘤受试者中的ORR;
次要目的:评估HEC169096在RET融合NSCLC、RET突变MTC及其他RET改变晚期实体瘤受试者中的其他抗肿瘤疗效指标(DCR、DOR、CNS ORR、CNS DOR、CBR、PFS,OS);
评估HEC169096在RET融合NSCLC、RET突变MTC及其他RET改变晚期实体瘤受试者中安全性和耐受性;
观察HEC169096在RET融合NSCLC、RET突变MTC及其他RET改变晚期实体瘤受试者中的PK特征和药物代谢转化。
[Translation] Phase I:
Primary purpose: to determine the maximum tolerated dose (MTD)/phase II recommended dose (RP2D) of HEC169096;
Secondary purpose: to evaluate the safety and tolerability of HEC169096 in subjects with advanced solid tumors;
Observe the PK characteristics and drug metabolism conversion of HEC169096 in subjects with advanced solid tumors;
Evaluate the efficacy of HEC169096 in subjects with advanced solid tumors;
Phase II:
Primary purpose: to evaluate the ORR of HEC169096 in subjects with RET fusion NSCLC, RET mutation MTC and other RET-altered advanced solid tumors;
Secondary purpose: to evaluate other anti-tumor efficacy indicators (DCR, DOR, CNS ORR, CNS DOR, CBR, PFS, OS);
Evaluate the safety and tolerability of HEC169096 in subjects with RET fusion NSCLC, RET mutation MTC and other RET-altered advanced solid tumors;
Observe the PK characteristics and drug metabolism conversion of HEC169096 in subjects with RET fusion NSCLC, RET mutation MTC and other RET-altered advanced solid tumors.