Testing CDR404 for advanced solid tumors with specific markers
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
PHASE1 · CDR-Life AG · NCT06402201
This study is testing a new treatment called CDR404 for patients with advanced solid tumors that have a specific marker to see how safe it is and how well it works.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CDR-Life AG (industry) |
| Locations | 18 sites (Miami, Florida and 17 other locations) |
| Trial ID | NCT06402201 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates CDR404, a bispecific antibody designed to target MAGE-A4 expressing solid tumors in patients with the HLA-A*02:01 tissue marker. It aims to determine the maximum tolerated dose and pharmacologically effective dose range of CDR404 while assessing its safety, tolerability, and preliminary anti-tumor activity. The study will also characterize the pharmacokinetics and immunogenicity of CDR404 and evaluate translational biomarkers in participants with advanced solid tumors that are relapsed, refractory, or intolerant to standard therapies.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced solid tumors that express MAGE-A4 and have the HLA-A*02:01 marker.
Not a fit: Patients with untreated central nervous system metastasis or significant ongoing toxicity from prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with specific advanced solid tumors.
How similar studies have performed: While this approach is novel, similar studies targeting specific tumor-associated antigens have shown promise in early phases.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida and 17 other locations
- University of Miami — Miami, Florida, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Providence Cancer Institute — Portland, Oregon, United States (RECRUITING)
- Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)
- Universitair Ziekenhuis Antwerpen — Antwerp, Belgium (RECRUITING)
- Institut Jules Bordet — Brussels, Belgium (RECRUITING)
- Cliniques Universitaires Saint-Luc, UCL Ouvain — Brussels, Belgium (RECRUITING)
- Universitair Ziekenhuis Gent — Ghent, Belgium (RECRUITING)
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- Istituto Clinico Humanitas — Milan, Italy (RECRUITING)
- Isituto Europeo di Oncologia (IEO) — Milan, Italy (RECRUITING)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (RECRUITING)
- Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO) — Barcelona, Spain (RECRUITING)
- Hospital 12 de Octubre — Madrid, Spain (RECRUITING)
- START Madrid — Madrid, Spain (RECRUITING)
- Hospital Universitari i Politecnic La Fe — Valencia, Spain (RECRUITING)
- Instituto de Investigacion Sanitaria (INCLIVA) — Valencia, Spain (RECRUITING)
- Royal Marsden Hospital — Sutton, London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Dimitrios Chondros Chief Medical Officer, CDR-Life
- Email: CDR404-001_Study@CDR-Life.com
- Phone: +41 44 515 7025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Select Advanced Solid Tumors