Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-25 @ 4:27 PM
Study NCT ID:
NCT04319757
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2020-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
Sponsor:
Acepodia Biotech, Inc.
Organization:
Study Overview
Official Title:
A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
Status:
COMPLETED
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:
ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?: