Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04518137
Status:
TERMINATED
Last Update Posted:
2023-01-31
First Post:
2020-08-15
Brief Title:
A Study of Evaluating the Safety and Efficacy of ATG-008 for Advanced Solid Tumors BUNCH
Sponsor:
Shanghai Antengene Corporation Limited
Organization:
Antengene Corporation
Study Overview
Official Title:
An Open-Label Single-Arm Basket Study of ATG-008 for the Treatment of Patients With Advanced Solid Tumors Harboring NFE2L2 STK11 RICTOR or Other Specific Genetic Alterations
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the low popularity of NGS testing in China and the small number of target subjects our company decided to adjust the research and development strategy terminate this study and not apply for new drug registration after careful consideration
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm and open-label study of ATG-008 for the Treatment of Patients With advanced Solid Tumors harboring NFE 2L2 STK11 RICTOR or other specific genetic alterationts
Detailed Description:
This is a single-arm and open-label study Approximately 10-12 patients will be enrolled per each genetic alterration group in the study ATG-008 is the monotherapy for advanced solid tumors with 30mg QD The clinical efficacy safety and tolerability of ATG-008 will be evaluated Addtionalal dose levels may apply after the efficacysafety and tolerabitly of 30mg QD has been accessed by Sponosor and study steering committee
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