[Translation] A Phase I study evaluating the safety, tolerability, and pharmacokinetics of the oral pan-RAF inhibitor QLH11906 in subjects with advanced solid tumors with abnormal MAPK pathways
主要研究目的:评估不同剂量QLH11906单药治疗复发/难治性、不可切除的局部晚期或转移性MAPK通路异常的晚期实体瘤的安全性及耐受性,确定MTD/最大给药剂量(Maximum Administered Dose, MAD,如果无法确定MTD)和RP2D。次要研究目的:1.评估QLH11906在MAPK通路异常的晚期实体瘤患者中的初步疗效。2.评估QLH11906在MAPK通路异常的晚期实体瘤患者中PK特征。3.通过对QTcF间期延长与QLH11906浓度进行建模分析评价QLH11906对患者QTcF间期延长的影响。。
[Translation] The main purpose of the study is to evaluate the safety and tolerability of different doses of QLH11906 monotherapy in the treatment of relapsed/refractory, unresectable locally advanced or metastatic advanced solid tumors with abnormal MAPK pathways, and to determine the MTD/maximum Administered Dose (MAD, if MTD cannot be determined) and RP2D. Secondary study objectives: 1. To evaluate the preliminary efficacy of QLH11906 in patients with advanced solid tumors with abnormal MAPK pathways. 2. To evaluate the PK characteristics of QLH11906 in patients with advanced solid tumors with abnormal MAPK pathways. 3. To evaluate the effect of QLH11906 on the prolongation of the QTcF interval in patients by modeling and analyzing the prolongation of the QTcF interval and the concentration of QLH11906. .