Actively Recruiting
First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
Led by CDR-Life AG · Updated on 2026-02-27
42
Participants Needed
18
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Positive for HLA-A*02:01
- Tumor positive for MAGE-A4
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Have selected advanced solid tumors
- Relapsed, refractory, or intolerant to standard therapy
- Measurable disease according to RECIST v1.1
- Have adequate organ function
- Agree to use highly effective contraception if applicable
You will not qualify if you...
- Symptomatic or untreated central nervous system metastasis
- Insufficient washout from prior anticancer therapy
- Significant ongoing toxicity from prior anticancer treatment
- Recent surgery
- Clinically significant heart disease
- Active infection requiring systemic antibiotics
- Risk of HIV/AIDS-related outcomes
- Active hepatitis B or C infection
- Ongoing systemic steroid or immunosuppressive treatment
- Significant secondary cancer
- History of chronic or recurrent active autoimmune disease needing treatment
- Uncontrolled illness
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 18 locations
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Providence Cancer Institute
Portland, Oregon, United States, 97213
Actively Recruiting
4
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
5
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium, 2650
Actively Recruiting
6
Institut Jules Bordet
Brussels, Belgium, 1070
Actively Recruiting
7
Cliniques Universitaires Saint-Luc, UCL Ouvain
Brussels, Belgium, 1200
Actively Recruiting
8
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
9
Rigshospitalet
Copenhagen, Denmark, DK-2100
Actively Recruiting
10
Istituto Clinico Humanitas
Milan, Italy, 20089
Actively Recruiting
11
Isituto Europeo di Oncologia (IEO)
Milan, Italy, 20141
Actively Recruiting
12
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
13
Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)
Barcelona, Spain, 08908
Actively Recruiting
14
Hospital 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
15
START Madrid
Madrid, Spain, 28050
Actively Recruiting
16
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
17
Instituto de Investigacion Sanitaria (INCLIVA)
Valencia, Spain, 46026
Actively Recruiting
18
Royal Marsden Hospital
Sutton, London, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
D
Dimitrios Chondros Chief Medical Officer, CDR-Life
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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