Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-29 @ 8:01 PM
Study NCT ID:
NCT06511895
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27)
Sponsor:
Dizal Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase II, Open-Label, Single-Arm Study to Investigate the Safety, Tolerability, and Anti-tumor Activity of AZD4205 Treating Relapsed or Refractory Peripheral T Cell Lymphoma (r/r PTCL)
Status:
COMPLETED
Status Verified Date:
2025-12
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:
This is a phase II, open label, multicenter study of AZD4205 administered orally in participants with r/r PTCL to determine its safety, tolerability, PK, and anti-tumor activity. Eligible participants are those who had pathologically confirmed PTCL and have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen. The primary objective of this study is to evaluate anti-tumor efficacy of AZD4205 at 150 mg once daily (RP2D) in participants with r/r PTCL. The safety, tolerability, and PK of AZD4205 in r/r PTCL at RP2D will also be investigated.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: