RecruitingPhase 1NCT06402201

First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

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

Sponsor

CDR-Life AG

Enrollment

42 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

Select Advanced Solid Tumors

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CDR404 for people with select advanced solid tumors. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCDR404

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

View Full Details on ClinicalTrials.gov

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NCT06402201

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