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First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
Sponsor: CDR-Life AG
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-A\*02:01 tissue marker and whose cancer is positive for MAGE-A4.
Official title: Phase 1, First-in-Human Study to Assess the Safety, Tolerability and Anti-tumor Activity of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2024-05-24
Completion Date
2027-12-31
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
CDR404
IV infusions
Locations (18)
University of Miami
Miami, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Providence Cancer Institute
Portland, Oregon, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Institut Jules Bordet
Brussels, Belgium
Cliniques Universitaires Saint-Luc, UCL Ouvain
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Rigshospitalet
Copenhagen, Denmark
Istituto Clinico Humanitas
Milan, Italy
Isituto Europeo di Oncologia (IEO)
Milan, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)
Barcelona, Spain
Hospital 12 de Octubre
Madrid, Spain
START Madrid
Madrid, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Instituto de Investigacion Sanitaria (INCLIVA)
Valencia, Spain
Royal Marsden Hospital
Sutton, London, United Kingdom