[Translation] An open-label, multiple-dose, dose-escalation, and cohort expansion phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of sinalitoxaban injection in patients with advanced solid tumors
主要目的:
1.评估注射用信立他赛的安全性和耐受性。
2.确定注射用信立他赛的最大耐受剂量(MTD)和/或Ⅱ期临床试验推荐剂量(RP2D)。
次要目的:
1.评估注射用信立他赛的药代动力学(PK)特征。
2.初步评估注射用信立他赛的抗肿瘤疗效。
探索目的:
1.监测注射用信立他赛药效学相关的生物标志物:在受试者中寻找有效的生物标志物。
2.探索注射用信立他赛抗肿瘤的预测性生物标志物:包括肿瘤组织核苷酸结合寡聚化结构域(NOD)1/2等的表达水平。
[Translation] Main objectives:
1. Evaluate the safety and tolerability of xinlitaxel for injection.
2. Determine the maximum tolerated dose (MTD) and/or recommended dose (RP2D) of xinlitaxel for injection.
Secondary objectives:
1. Evaluate the pharmacokinetic (PK) characteristics of xinlitaxel for injection.
2. Preliminary evaluation of the anti-tumor efficacy of xinlitaxel for injection.
Exploration objectives:
1. Monitor biomarkers related to the pharmacodynamics of xinlitaxel for injection: Find effective biomarkers in subjects.
2. Explore predictive biomarkers for the anti-tumor effect of xinlitaxel for injection: including the expression levels of nucleotide binding oligomerization domain (NOD) 1/2 in tumor tissues.