Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402201
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-04-25
Brief Title:
First in Human Study of CDR404 in HLA-A0201 Participants With MAGE-A4 Expressing Solid Tumors
Sponsor:
CDR-Life AG
Organization:
CDR-Life AG
Study Overview
Official Title:
Phase 1 First-in-Human Study to Assess the Safety Tolerability and Anti-tumor Activity of CDR404 in HLA-A0201 Participants With MAGE-A4 Expressing Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
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:
CDR404 is a highly potent and specific T-cell engaging bispecific and bivalent antibody designed for the treatment of cancers positive for the tumor-associated antigen melanoma-associated antigen 4 MAGE-A4 This is a first-in-human study designed to evaluate the safety tolerability and preliminary anti-tumor activity of CDR404 in adult patients who have the appropriate germline human leukocyte antigen HLA-A0201 tissue marker and whose cancer is positive for MAGE-A4
Detailed Description:
The CDR404-001 Phase 1 study will enrol patients with locally advanced unresectable or metastatic tumors expressing MAGE-A4 which include advanced solid tumors and will be conducted in multiple phases
1 To identify the maximum tolerated dose MTD and pharmacologically effective dose range PEDR for CDR404
2 To assess preliminary evidence of anti-tumor activity of CDR404
3 To characterise the pharmacokinetics of CDR404
4 To characterise the immunogenicity of CDR404
5 To assess translational biomarkers
1 To identify the maximum tolerated dose MTD and pharmacologically effective dose range PEDR for CDR404
2 To assess preliminary evidence of anti-tumor activity of CDR404
3 To characterise the pharmacokinetics of CDR404
4 To characterise the immunogenicity of CDR404
5 To assess translational biomarkers
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