Ignite Creation Date:
2025-12-18 @ 9:50 AM
Ignite Modification Date:
2025-12-18 @ 9:50 AM
Study NCT ID:
NCT05046314
Status:
None
Last Update Posted:
2024-12-20 00:00:00
First Post:
2021-08-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of TK216 in Patients With Relapsed or Refractory Ewing's Sarcoma
Sponsor:
None
Organization:
Study Overview
Official Title:
The Efficacy and Safety of TK216 in Subjects With Relapsed or Refractory Ewing's Sarcoma：a Phase II Clinical Trial in China
Status:
None
Status Verified Date:
2024-12
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:
Ewing sarcoma is characterized by genomic rearrangements resulting in over-expression of ets family transcription factors driving tumor progression. TK216 is designed to inhibit this effect by inhibiting downstream effects of the EWS-FLI1 transcription factor. Based on USA RP2D result, designed as a single arm, multicenter open-label study，this study is the first study of TK216 in Chinese subjects with Ewing sarcoma. The study is designed to establish safety and efficacy data in combination with vincristine to assess the potential of TK216 for further development.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: