drugset / Trial / NCT04237805
A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients
NaSingle-groupOpen-labelTreatment
Summary
The study comprises two phases: phase I dose escalation (including PK run-in period and treatment period) and phase II study.
Timeline
- Start
- 2016-11-14
- Primary completion
- 2022-12-31
- Completion
- 2026-03-31
Publications
- Yang JJ, Zhou J, Liu SM, Li M, Zhang Z, Cheng Y, Fan Y, Pan H, Wang B, Chen G, Wang K, Jiang L, Hu Y, Shi J, Dong X, Ding C, Liu Y, Liu Z, Liao W, Li W, Wang J, Yi S, Zhao Q, Zang A, Chen Y, Cui J, Luo P, Shen X, Sun M, Wang C, Wu YL; SAF001 study group. Foritinib in advanced ROS1-rearranged non-small-cell lung cancer in China: a multicentre, open-label, single-arm, phase 2 study. Lancet Respir Med. 2024 Sep;12(9):671-680. doi: 10.1016/S2213-2600(24)00171-1. Epub 2024 Jul 23.
- Xia ZJ, Ji YC, Sun DQ, Peng X, Gao YL, Fang YF, Zhao XD, Wang WB, Ding J, Geng MY, Ai J. SAF-189s, a potent new-generation ROS1 inhibitor, is active against crizotinib-resistant ROS1 mutant-driven tumors. Acta Pharmacol Sin. 2021 Jun;42(6):998-1004. doi: 10.1038/s41401-020-00513-3. Epub 2020 Sep 11.