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Looking for participantsPhase1

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

Sponsor: CDR-Life AG

NCT ID: NCT06402201

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
CDR404 (biological)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
CDR404 — biological: IV infusions
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
42
Started
2024-05-24
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for select advanced solid tumors
  • • Phase1 - 42 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with select advanced solid tumors

Where?

  • • Sutton - Royal Marsden Hospital
  • • Glasgow - The Beatson West of Scotland Cancer Center
  • • London - Guys and St Thomas' NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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

Select Advanced Solid Tumors

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

01 positiveA4 positive

What the study is looking for

  • ✓Provision of written agreement to take part
  • ✓HLA-A\*02:01 positive
  • ✓MAGE-A4 positive tumor
  • ✓activity scale (ECOG) performance status (PS) \[ECOG PS\] 0 or 1
  • ✓Selected advanced solid tumors

Who cannot take part

  • ✗causing symptoms or untreated central nervous system metastasis
  • ✗Inadequate washout from prior anticancer therapy
  • ✗Significant ongoing toxicity from prior anticancer treatment
  • ✗Recent surgery
  • ✗Clinically significant heart disease
See the full 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 Is This Study? (3 UK sites)

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Alec MD PaschalisPrincipal Investigator
Ekta Gosha+442089154409Ekta.Goshi@icr.ac.uk

The Beatson West of Scotland Cancer Center

Glasgow, United Kingdom

Recruiting
Site contact (verified)
Jeff EvansPrincipal Investigator
Jeff Evans(+44)1413017073j.evans@crukscotlandinstitute.ac.uk

Guys and St Thomas' NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Rebecca KristeleitPrincipal Investigator
Early Phase Research Team(+44)20 7188 8103gstt.earlyphaseresearchteam@nhs.net

How to Get in Touch

Dimitrios Chondros Chief Medical Officer, CDR-Life

Sponsor contact

CONTACT

+41 44 515 7025 CDR404-001_Study@CDR-Life.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09