NCT06402201From ClinicalTrials.govRecruiting

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

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

Select Advanced Solid Tumors

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: CDR-Life AG
Enrolment target: 42
Started: 24 May 2024
Main results due: 30 December 2026
Study sites: 20
Registry updated: 24 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(20)

University of Miami
Miami, Florida, United States
Withdrawn
University of Michigan
Ann Arbor, Michigan, United States
Withdrawn
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
The Beatson West of Scotland Cancer Center
Glasgow, United Kingdom
Recruiting
Guys and St Thomas' NHS Foundation Trust
London, United Kingdom
Not yet recruiting

Showing 20 of 20 sites. 17 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06402201. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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