Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05955391
Status:
RECRUITING
Last Update Posted:
2023-07-21
First Post:
2023-07-10
Brief Title:
TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer NSCLC
Sponsor:
Shenzhen TargetRx Inc
Organization:
Shenzhen TargetRx Inc
Study Overview
Official Title:
A Multi-centered Open-label Single-arm Phase II Study to Evaluate the Safety and Efficacy of TGRX-326 Monotherapy in Patients of Advanced ALK-positiveNon-Small Cell Lung Cancer Who Failed 2nd-Generation ALK Inhibitor Therapies
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center single-arm open-label Phase II clinical trial which explores the safety and efficacy of TGRX-326 in patients with ALK-positive advanced NSCLC who have failed prior 2nd-generation ALK treatments due to progressive disease or intolerance
Detailed Description:
This Phase II studyaims to evaluate the safety profile and efficacy profile in patients with ALK-positive advanced NSCLC The primary purpose of this study is to evaluate the efficacy profile of TGRX-326 with the objective response rate ORR as end point Secondary objectives include evaluating efficacy profile of other endpoints and safety profiles of the investigational drug Exploratory objective includes the evaluation of population pharmacokinetic PK profile of TGRX-326
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None