drugset / Trial / NCT03389815
A Study Evaluates the Safety, Pharmacokinetics and Efficacy of WX-0593 in Advanced Solid Tumor Patients
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of WX-0593 alone in the treatment of advanced cancer.
Timeline
- Start
- 2017-09-14
- Primary completion
- 2020-06
- Completion
- 2020-12
Publications
- Yang G, Wang Y, Zhao H, Zheng Q, Wang X, Jia L, Xin Q, Ma C, Zhang Y, Zheng S, Kang X. Translational Model-Informed Dose Selection for Iruplinalkib, a Selective Oral ALK/ROS1 Tyrosine Kinase Inhibitor. Clin Transl Sci. 2025 Jul;18(7):e70287. doi: 10.1111/cts.70287.
- Shi Y, Fang J, Hao X, Zhang S, Liu Y, Wang L, Chen J, Hu Y, Hang X, Li J, Liu C, Zhang Y, Wang Z, Hu Y, Gu K, Huang J, Zhang L, Shan J, Ouyang W, Zhao Y, Zhuang W, Yu Y, Zhao J, Zhang H, Lu P, Li W, Si M, Ge M, Geng H. Safety and activity of WX-0593 (Iruplinalkib) in patients with ALK- or ROS1-rearranged advanced non-small cell lung cancer: a phase 1 dose-escalation and dose-expansion trial. Signal Transduct Target Ther. 2022 Jan 28;7(1):25. doi: 10.1038/s41392-021-00841-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | WX-0593 | Small molecule | 30 mg | Oral |
| Subject | WX-0593 | Small molecule | 300 mg | Oral |