TGRX-326 Chinese Phase I for Advanced Non-small Cell Lung Cancer (NSCLC)

Summary

This trial is a multi-center, single-arm, open-label, Phase I clinical trial in 3 phases: dose escalation phase, dose expansion phase and indication expansion phase, which will explore the safety, tolerability, PK and preliminary efficacy of TGRX-326 in patients with ALK-positive or ROS1-positive advanced NSCLC.

Timeline

Start

2021-04-23

Primary completion

2025-08-31

Completion

2025-10-31

Publications

• Zhao S, Zhou H, Yang N, Wang Z, Jin W, Ma Y, Xue J, Li X, Liu Y, Meng R, Zhou J, Cheng Y, Wang Y, Yu Z, Cao Y, Zhao Y, Huang Y, Fang W, Zhang Y, Hong S, Wu B, Shi Y, Cao J, Xu M, Zhang X, Hu L, Peng B, Yang Y, Zhang L, Zhao H. Safety, Efficacy, and Biomarker Analysis of Deulorlatinib (TGRX-326) in Anaplastic Lymphoma Kinase-Positive NSCLC: A Multicenter, Open-Label, Phase 1/1b Trial. J Thorac Oncol. 2025 Jun;20(6):750-762. doi: 10.1016/j.jtho.2024.11.010. Epub 2024 Nov 15.

Drugs

Indications