First-in-Human Study of CDR404 for MAGE-A4 Positive Solid Tumors

This study is testing a new treatment called CDR404 for people with certain advanced solid tumors that have a specific marker called MAGE-A4. CDR404 is a biological treatment given through IV infusions. It's designed to help your body's immune system fight cancer cells. To join, you must have the HLA-A*02:01 tissue marker, MAGE-A4 positive cancer, and your cancer must have progressed despite standard treatments. Researchers want to see how safe CDR404 is, what side effects it might cause, and if it can shrink tumors. The study is currently recruiting about 42 participants.

Study design
This is a first-in-human interventional study with a planned enrollment of 42 participants. It is designed to find the best dose of CDR404 and assess its initial effects.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for side effects for 90 days after your last dose. They will also track your anti-tumor response until your disease progresses or you pass away, for up to 100 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06402201

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
CDR-Life AG
~42 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:CDR404

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of dose limiting toxicities (DLTs)
Measured over From first dose to DLT period (21 days)
+2 more outcomes measured
Select Advanced Solid Tumors

NCT06402201

Where you'd take part

This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cliniques Universitaires Saint-Luc, UCL Ouvain

    Brussels, Belgiumstudy coordinator listed

    Recruiting

  • Hospital 12 de Octubre

    Madrid, Spainstudy coordinator listed

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, Spainstudy coordinator listed

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spainstudy coordinator listed

    Recruiting

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

    Barcelona, Spainstudy coordinator listed

    Recruiting

  • Institut Jules Bordet

    Brussels, Belgiumstudy coordinator listed

    Recruiting

  • Instituto de Investigacion Sanitaria (INCLIVA)

    Valencia, Spainstudy coordinator listed

    Recruiting

  • Isituto Europeo di Oncologia (IEO)

    Milan, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Dimitrios Chondros Chief Medical Officer, CDR-Life
Email the study team

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  • Presence of dose limiting toxicities (DLTs)From first dose to DLT period (21 days)

    per Protocol

  • Incidence and severity of (serious) adverse events ([S]AEs)From first dose to 90 days after the last dose

    AEs, SAEs

  • Anti-tumor response: Overall Response Rate (ORR)From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

    per RECIST 1.1