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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: CDR-Life AG • ClinicalTrials.gov ID: NCT06402201

Registry updated: 2026-09-24
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Description

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.

Interventions

  • CDR404 (Biological)
    IV infusions

Eligibility criteria

Inclusion Criteria: 1. Provision of written informed consent 2. HLA-A\*02:01 positive 3. MAGE-A4 positive tumor 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 0 or 1 5. Selected advanced solid tumors 6. Relapsed from, refractory to, or intolerant of standard therapy 7. Measurable disease per RECIST v1.1 8. Adequate organ function 9. If applicable, must agree to use highly effective contraception Exclusion Criteria: 1. Symptomatic or untreated central nervous system metastasis 2. Inadequate washout from prior anticancer therapy 3. Significant ongoing toxicity from prior anticancer treatment 4. Recent surgery 5. Clinically significant cardiac disease 6. Active infection requiring systemic antibiotic treatment 7. Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes 8. Active hepatitis B virus (HBV) or hepatitis C virus (HBC) 9. Ongoing treatment with systemic steroids or other immunosuppressive therapies 10. Significant secondary malignancy 11. History of chronic or recurrent active autoimmune disease requiring treatment 12. Uncontrolled intercurrent illness 13. Pregnancy or lactation.

Conditions

Select Advanced Solid Tumors

Locations

  • 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
  • The Beatson West of Scotland Cancer Center — Glasgow, United Kingdom
  • Guys and St Thomas' NHS Foundation Trust — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record