Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
NCT06402201 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- BIOLOGICAL CDR404
Study Locations (18)
Other
- Universitair Ziekenhuis Antwerpen — Antwerp
- Institut Jules Bordet — Brussels
- Cliniques Universitaires Saint-Luc, UCL Ouvain — Brussels
- Universitair Ziekenhuis Gent — Ghent
- Rigshospitalet — Copenhagen
- Istituto Clinico Humanitas — Milan
- Isituto Europeo di Oncologia (IEO) — Milan
- Hospital Universitari Vall d'Hebron — Barcelona
- Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO) — Barcelona
- Hospital 12 de Octubre — Madrid
- START Madrid — Madrid
- Hospital Universitari i Politecnic La Fe — Valencia
- Instituto de Investigacion Sanitaria (INCLIVA) — Valencia
Florida
- University of Miami — Miami
Michigan
- University of Michigan — Ann Arbor
Oregon
- Providence Cancer Institute — Portland
Pennsylvania
- Pennsylvania Hospital — Philadelphia
London
- Royal Marsden Hospital — Sutton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2024-05-24 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06402201
The ClinicalTrials.gov registry entry for NCT06402201 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CDR-Life, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Select Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which CDR404 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06402201 reports 18 study locations spanning 6 distinct geographic areas — top geographies include Other, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06402201 about?
NCT06402201 is a clinical study titled "First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors". 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 prelimina...
What is the current status of trial NCT06402201?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2024-05-24. Estimated completion is 2027-12-31.
What conditions does trial NCT06402201 study?
This clinical trial studies the following conditions: Select Advanced Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06402201?
The interventions under investigation include: CDR404 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06402201?
This trial is sponsored by CDR-Life, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06402201 being conducted?
This trial has 18 study locations across Florida, Michigan, Oregon, Pennsylvania, London. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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