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

Last updated: April 11, 2025
Sponsor: CDR-Life AG
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

CDR404

Clinical Study ID

NCT06402201
CDR404-001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

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.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: CDR404
Phase: 1
Study Start date:
May 24, 2024
Estimated Completion Date:
December 31, 2027

Study 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

Connect with a study center

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc, UCL Ouvain

    Brussels, 1200
    Belgium

    Active - Recruiting

  • Institut Jules Bordet

    Brussels, 1070
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, DK-2100
    Denmark

    Active - Recruiting

  • Isituto Europeo di Oncologia (IEO)

    Milan, 20141
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Milan, 20089
    Italy

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • START Madrid

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Instituto de Investigacion Sanitaria (INCLIVA)

    Valencia, 46026
    Spain

    Active - Recruiting

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Providence Cancer Institute

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania 19106
    United States

    Active - Recruiting

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