Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007482
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-08-10
Brief Title:
A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Elpiscience Biopharma Australia Pty Ltd
Organization:
Elpiscience Biopharma Ltd
Study Overview
Official Title:
An Open-Label Multicenter First-in-Human Phase 1 Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-09
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:
The goal of this clinical trial is to evaluate the safety tolerability pharmacokinetics pharmacodynamics and preliminary clinical activity of ES009 administered intravenously to subjects with advanced solid tumors
Detailed Description:
ES009 is a recombinant humanized IgG4 monoclonal antibody that specifically targets and blocks LILRB2 By reprograming suppressive myeloid cells into pro-inflammatory phenotypes ES009 reshapes the immunosuppressive tumor microenvironment into an immune-favorable one to combat cancer development and progression
This is a first-in-human open-label multicenter non-randomized study designed to determine the maximum tolerated dose MTDmaximum administered dose MAD optimal biological dose OBD and recommended phase 2 dose RP2D of ES009 by evaluating the safety tolerability pharmacokinetics pharmacodynamics and preliminary clinical activity of ES009 administered intravenously to subjects with advanced solid tumors
This is a first-in-human open-label multicenter non-randomized study designed to determine the maximum tolerated dose MTDmaximum administered dose MAD optimal biological dose OBD and recommended phase 2 dose RP2D of ES009 by evaluating the safety tolerability pharmacokinetics pharmacodynamics and preliminary clinical activity of ES009 administered intravenously to subjects with advanced solid tumors
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