[Translation] A Phase I/II clinical study to evaluate the safety and efficacy of HS301 in the treatment of locally advanced or metastatic solid tumors with NTRK, ROS1 or ALK gene mutations
I期主要目的:观察HS301治疗局部晚期或转移性实体瘤患者的安全性和耐受性;评估HS301治疗局部晚期或转移性实体瘤患者的DLT和MTD。次要目的:评估HS301治疗局部晚期或转移性实体瘤患者的药代动力学特征;评估HS301治疗局部晚期或转移性实体瘤患者的初步疗效。II期主要目的:进一步观察HS301治疗NTRK或ROS1或ALK基因突变阳性局部晚期或转移性实体瘤的疗效。次要目的:观察HS301治疗NTRK或ROS1或ALK基因突变阳性局部晚期或转移性实体瘤的安全性。
[Translation] The primary objectives of Phase I are to observe the safety and tolerability of HS301 in the treatment of patients with locally advanced or metastatic solid tumors; to evaluate the DLT and MTD of HS301 in the treatment of patients with locally advanced or metastatic solid tumors. Secondary objectives are to evaluate the pharmacokinetic characteristics of HS301 in the treatment of patients with locally advanced or metastatic solid tumors; to evaluate the preliminary efficacy of HS301 in the treatment of patients with locally advanced or metastatic solid tumors. The primary objectives of Phase II are to further observe the efficacy of HS301 in the treatment of locally advanced or metastatic solid tumors with positive NTRK, ROS1, or ALK gene mutations. Secondary objectives are to observe the safety of HS301 in the treatment of locally advanced or metastatic solid tumors with positive NTRK, ROS1, or ALK gene mutations.