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JNSW10032 治疗急性骨髓性白血病的安全性、药代动力学和药效动力学的 I 期临床研究
[Translation] Phase I clinical study of the safety, pharmacokinetics and pharmacodynamics of JNSW10032 in the treatment of acute myeloid leukemia
主要研究目的
评估成人急性髓系白血病患者口服JNSW10032单药治疗的最大耐受剂量(MTD)及Ⅱ期研究的推荐剂量
(RP2D)
次要研究目的
评估成人急性髓系白血病患者口服JNSW10032单药治疗的安全性和耐受性
评估成人急性髓系白血病患者口服JNSW10032单药治疗的药代动力学(PK)特征
评估成人急性髓系白血病患者口服JNSW10032单药治疗的初步疗效 探索性研究目的
评估生物标记物与疗效的关系
[Translation] Main study objectives
To evaluate the maximum tolerated dose (MTD) of oral JNSW10032 monotherapy in adult patients with acute myeloid leukemia and the recommended dose for phase II study
(RP2D)
Secondary study objectives
To evaluate the safety and tolerability of oral JNSW10032 monotherapy in adult patients with acute myeloid leukemia
To evaluate the pharmacokinetic (PK) characteristics of oral JNSW10032 monotherapy in adult patients with acute myeloid leukemia
To evaluate the preliminary efficacy of oral JNSW10032 monotherapy in adult patients with acute myeloid leukemia Exploratory study objectives
To evaluate the relationship between biomarkers and efficacy
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100 Translational Medicine associated with Chongqing Qiuwen Biotechnology Co. Ltd.