Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415487
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-30
Brief Title:
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor EGFR
Sponsor:
Acepodia Biotech Inc
Organization:
Acepodia Biotech Inc
Study Overview
Official Title:
A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016 an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell gdT Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor EGFR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ACE2016 is an off-the-shelf allogeneic gamma delta T gdT cell therapy derived from healthy donors that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor EGFR
The ACE2016-001 study is an open-label Phase I first-in-human FIH study that aims to evaluate the safety and tolerability persistency pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor EGFR
The ACE2016-001 study is an open-label Phase I first-in-human FIH study that aims to evaluate the safety and tolerability persistency pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor EGFR
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?:
None