[Translation] A multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BY101921 alone or in combination with aPD-1 monoclonal antibody in patients with advanced malignant solid tumors
主要目的:
1)评价BY101921在晚期实体瘤患者中的安全性、耐受性
2)确定BY101921的最大耐受剂量(MTD)
次要目的:
1)评价BY101921在晚期实体瘤患者中的药代动力学(PK)特征
2)初步评估BY101921在晚期实体瘤患者中的有效性
探索性目的:
1)评估BY101921在晚期恶性实体瘤患者血浆中的代谢物谱
2)评估BY101921在晚期恶性实体瘤患者中的预测性生物标志物与有效性的关系
[Translation] Primary objectives:
1) Evaluate the safety and tolerability of BY101921 in patients with advanced solid tumors
2) Determine the maximum tolerated dose (MTD) of BY101921
Secondary objectives:
1) Evaluate the pharmacokinetic (PK) characteristics of BY101921 in patients with advanced solid tumors
2) Preliminary evaluation of the effectiveness of BY101921 in patients with advanced solid tumors
Exploratory objectives:
1) Evaluate the metabolite profile of BY101921 in plasma of patients with advanced malignant solid tumors
2) Evaluate the relationship between predictive biomarkers and effectiveness of BY101921 in patients with advanced malignant solid tumors