[Translation] A single-arm, open-label, Phase IIb clinical study evaluating the efficacy and safety of ABP1011T tablets in patients with locally advanced unresectable or metastatic osteosarcoma
主要目的
1) 评估ABP1011T片在局部晚期不可切除或转移性骨肉瘤患者中的有效性。
次要目的
1) 评估ABP1011T片在局部晚期不可切除或转移性骨肉瘤患者中的安全性。
探索性目的
1) 评估ABP1011T片在局部晚期不可切除或转移性骨肉瘤患者中的药代动力学特征。
2) 探索性研究局部晚期不可切除或转移性骨肉瘤患者生物标志物与疗效的关系。
[Translation] Primary Objectives
1) To evaluate the efficacy of ABP1011T tablets in patients with locally advanced, unresectable, or metastatic osteosarcoma.
Secondary Objectives
1) To evaluate the safety of ABP1011T tablets in patients with locally advanced, unresectable, or metastatic osteosarcoma.
Exploratory Objectives
1) To evaluate the pharmacokinetic profile of ABP1011T tablets in patients with locally advanced, unresectable, or metastatic osteosarcoma.
2) To exploratoryally investigate the relationship between biomarkers and efficacy in patients with locally advanced, unresectable, or metastatic osteosarcoma.