[Translation] Phase I/II clinical trial of TL139 in patients with locally advanced or metastatic tumors that are positive for NTRK, ROS1, or ALK fusion genes
I期:
主要目的:
评价 TL139治疗携带NTRK、ROS1或ALK融合基因阳性的局部晚期或转移性肿瘤患者的安全性和耐受性,探索最大耐受剂量(MTD),并选择Ⅱ期临床试验推荐剂量(RP2D)。
次要目的:
(1) 评价TL139的药代动力学特征。
(2) 初步评价TL139的抗肿瘤疗效。
(3) 评价高脂食物对TL139的影响。
II期:
主要目的:
评价 TL139治疗携带NTRK、ROS1或ALK融合基因阳性的局部晚期或转移性肿瘤患者的有效性。
次要目的:
(1) 评价 TL139治疗携带NTRK、ROS1或ALK融合基因阳性的局部晚期或转移性肿瘤患者的安全性。
(2) 评价 TL139治疗携带NTRK、ROS1或ALK融合基因阳性的局部晚期或转移性肿瘤患者的群体药代动力学(PK)特征。
[Translation] Phase I:
Primary objectives:
To evaluate the safety and tolerability of TL139 in the treatment of patients with locally advanced or metastatic tumors carrying NTRK, ROS1 or ALK fusion genes, explore the maximum tolerated dose (MTD), and select the recommended dose (RP2D) for Phase II clinical trials.
Secondary objectives:
(1) To evaluate the pharmacokinetic characteristics of TL139.
(2) To preliminarily evaluate the anti-tumor efficacy of TL139.
(3) To evaluate the effect of high-fat food on TL139.
Phase II:
Primary objectives:
To evaluate the efficacy of TL139 in the treatment of patients with locally advanced or metastatic tumors carrying NTRK, ROS1 or ALK fusion genes.
Secondary objectives:
(1) To evaluate the safety of TL139 in the treatment of patients with locally advanced or metastatic tumors carrying NTRK, ROS1 or ALK fusion genes.
(2) To evaluate the population pharmacokinetic (PK) characteristics of TL139 in the treatment of patients with locally advanced or metastatic tumors carrying NTRK, ROS1 or ALK fusion genes.