At a glance
ClinicalIndex Comparison RecordPhase 1Active· 198 enrolled
Drug / intervention
TGRX-326drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Dose Escalation and Expansion Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-326 Monotherapy for the Treatment of Advanced ALK-positive or ROS1-positive Non-Small Cell Lung Cancer
In Brief
A Phase 1 clinical trial evaluating TGRX-326 for Non-small Cell Lung Cancer. Active but no longer recruiting, targeting 198 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesChina
CollaboratorsSun Yat-Sen University Cancer Center
Timeline
Phase 1ActiveOverdue
20222023202420252026
Enrollment StartApr 2021
First PostedJul 2022
Primary CompletionAug 2025
Study CompletionOct 2025
TodayJul 2026
First PostedJul 1, 2022
Enrollment StartApr 23, 2021
Primary CompletionAug 31, 2025
Study CompletionOct 31, 2025
TodayJul 1, 2026
Enrollment to primary: 4.4 yearsPosted 4 years ago
Interventions
TGRX-326drug
Participants are given TGRX-326 tablets orally at one of the dose levels as pre-determined.