A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer

Summary

This is a multicenter, open-label, dose escalation, and expansion human clinical study to observe the safety, tolerability, pharmacokinetics, and pharmacodynamics of XZP-3621 in single and multiple oral administrations in advanced NSCLC subjects with ALK rearrangement or ROS1 rearrangement, and to initially explore the efficacy of XZP-3621.The study was divided into two parts: dose escalation and dose expansion.

Timeline

Start

2019-03-12

Primary completion

2023-08-15

Completion

2023-08-15

Publications

• Ai X, Guo R, Zhang L, Fang J, Zhang Y, Chen J, Zhao J, Ye F, Wang S, Shi M, Zhang X, Zhang F, Li J, Wang L, Guo X, Xu L, Duan X, Hu Y, Lu S. Preclinical characterization and first-in-human, phase I trial of the novel ALK inhibitor dirozalkib in advanced non-small cell lung cancer. Eur J Cancer. 2026 Feb 25;235:116221. doi: 10.1016/j.ejca.2026.116221. Epub 2026 Jan 7.

Drugs

Indications