Clinical Trial

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

Active, Not Recruiting Phase 1
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Record status
This record was last updated May 18, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-06-29; most recent amendment 2025-05-16.
Status change: Recruiting → Active, Not Recruiting 2024-04-09
Trial Details
NCT Number NCT05441956
Lead Sponsor Shenzhen TargetRx Co., Ltd.
Collaborators: Sun Yat-Sen University Cancer Center
Conditions Non-small Cell Lung Cancer
Enrollment 198 participants
Start Date 2021-04-23
Primary Completion 2025-08-31 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-18