Select Advanced Solid TumorsPhase 1NCT06402201
First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
A Phase 1 study testing CDR404 in people with Select Advanced Solid Tumors, run by CDR-Life AG at 20 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Select Advanced Solid Tumors
- What is being tested?
- CDR404
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 24 May 2024to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- HLA-A*02:01 positive
- MAGE-A4 positive tumor
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1
- Selected advanced solid tumors
- Relapsed from, refractory to, or intolerant of standard therapy
Show all 9Show fewer
- Measurable disease per RECIST v1.1
- Adequate organ function
- If applicable, must agree to use highly effective contraception
Who cannot join
- Symptomatic or untreated central nervous system metastasis
- Inadequate washout from prior anticancer therapy
- Significant ongoing toxicity from prior anticancer treatment
- Recent surgery
- Clinically significant cardiac disease
- Active infection requiring systemic antibiotic treatment
Show all 13Show fewer
- Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes
- Active hepatitis B virus (HBV) or hepatitis C virus (HBC)
- Ongoing treatment with systemic steroids or other immunosuppressive therapies
- Significant secondary malignancy
- History of chronic or recurrent active autoimmune disease requiring treatment
- Uncontrolled intercurrent illness
- Pregnancy or lactation.
Trial locations and contacts
20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Dimitrios Chondros Chief Medical Officer, CDR-Life contact
20 sites in 6 countries
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Montserrat Moreno, +34 932543450 ext. 98814, momoreno@vhio.net
Alberto Hernando Calvo, MD
- Recruiting
Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)
Barcelona, 08908
Carmen Cuadra, +34 932607294, ccuadra@iconcologia.net
Ramon Salazar MD Martin, MD
- Recruiting
Hospital 12 de Octubre
Madrid, 28041
Sandra Tapial, Raquel Rodriguez, MariPaz Soriano,, +34913908922, unidadfase1.imas12@h12o.es
Sandra de la Llave, Marta Gutierrez, Elisa Lorente, Lidia Silvo, Veronica Silva
- Recruiting
START Madrid
Madrid, 28050
Ester Ordonez, +34 917567800 ext. 4851, ester.ordonez@startmadrid.com
Sonia Puerta, sonia.puerta@startmadrid.com
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Lorena, Jimenez, +34 618734852, lorena.jimenez@iislafe.es
Juan Genoves, juan.genoves@iislafe.es
- Recruiting
Instituto de Investigacion Sanitaria (INCLIVA)
Valencia, 46026
Maribel Gomez, +34 961973527, iblasco@incliva.es
Inma Blasco
United States4 sites, 2 recruiting
- Withdrawn
University of Michigan
Ann Arbor, Michigan, 48109
- Withdrawn
University of Miami
Miami, Florida, 33136
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Research Team, +1-215-829-7089, PAhemoncResearch@uphs.upenn.edu
Mark Diamond, MD
- Recruiting
Providence Cancer Institute
Portland, Oregon, 97213
Providence Cancer Institute, CanRsrchStudies@providence.org
+1-503-215-5763
Belgium4 sites, 4 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Antwerp, 2650
Amelie Lyssens, +32 38215580, studies.oncologie@uza.be
Hans Prenen, MD
- Recruiting
Institut Jules Bordet
Brussels, 1070
Michele Schroeder, +3225413833, michele.schroeder@hubruxelles.be
Nuria Kotecki, MD
- Recruiting
Cliniques Universitaires Saint-Luc, UCL Ouvain
Brussels, 1200
Jean-Pascal Machiels, MD, +32 27645457, jean-pascal.machiels@saintluc.uclouvain.be
Jean-Pascal Machiels, MD
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Tessa Lefebvre, +32 38215580, tessa.lefebvre@uzgent.be
Sylvie Rottey, MD
United Kingdom3 sites, 3 recruiting
- Recruiting
The Beatson West of Scotland Cancer Center
Glasgow
Jeff Evans, (+44)1413017073, j.evans@crukscotlandinstitute.ac.uk
Jeff Evans
- Not yet recruiting
Guys and St Thomas' NHS Foundation Trust
London
Early Phase Research Team, (+44)20 7188 8103, gstt.earlyphaseresearchteam@nhs.net
Rebecca Kristeleit
- Recruiting
Royal Marsden Hospital
Sutton, London, SM2 5PT
Ekta Gosha, +442089154409, Ekta.Goshi@icr.ac.uk
Alec MD Paschalis
Italy2 sites, 2 recruiting
- Recruiting
Istituto Clinico Humanitas
Milan, 20089
Matteo Simonelli, MD, +390282244559, matteo.simonelli@cancercenter.humanitas.it
Matteo Simonelli, MD
- Recruiting
Isituto Europeo di Oncologia (IEO)
Milan, 20141
Giuseppe Curigliano, MD, +390257489960, Giuseppe.curigliano@ieo.it
Guiseppe Curigliano, MD
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, DK-2100
Phase 1 Unit, +4535457966, RH-FP-ThePhase1Unit@regionh.dk
Iben Spanggaard, MD, +45 35 45 35 45, iben.spanggaard.01@regionh.dk
About this study
Official title: 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
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.
Read the detailed description
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:
- To identify the maximum tolerated dose (MTD) and pharmacologically effective dose range (PEDR) for CDR404
- To assess preliminary evidence of anti-tumor activity of CDR404
- To characterise the pharmacokinetics of CDR404
- To characterise the immunogenicity of CDR404
- To assess translational biomarkers
- Conditions
- Select Advanced Solid Tumors
- Being tested
- CDR404
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDR404Biological
IV infusions
| Study group | Role | What they receive |
|---|---|---|
| CDR404 | Experimental | Dose escalation Receives: Biological: CDR404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of dose limiting toxicities (DLTs)
per Protocol
Measured: From first dose to DLT period (21 days)
Incidence and severity of (serious) adverse events ([S]AEs)
AEs, SAEs
Measured: From first dose to 90 days after the last dose
Anti-tumor response: Overall Response Rate (ORR)
per RECIST 1.1
Measured: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Secondary outcomes (14)
Disease control rate (DCR)
per RECIST 1.1
Measured: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Duration of response (DOR)
per RECIST 1.1
Measured: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Progression-free Survival (PFS)
per RECIST 1.1
Measured: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Overall Survival (OS)
per RECIST 1.1
Measured: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Maximum serum concentration of CDR404 (Cmax)
following single and multiple dose administration
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Time to maximum serum concentration of CDR404 (Tmax)
following single and multiple dose administration
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Trough serum concentration of CDR404 (Ctrough)
following single and multiple dose administration
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Half-life of CDR404 (t1/2)
following single and multiple dose administration
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Area under the CDR404 serum concentration over time curve (AUC0-T)
to the end of the dosing interval following single and multiple dose administration
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Volume of CDR404 distribution (Vd)
following single and multiple dose administration
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Average serum concentration of CDR404 (Cavg)
following single and multiple dose administration
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Serum drug levels of CDR404 at steady state (CL)
following single and multiple dose administration
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Accumulation ratio of CDR404 (Rac)
following single and multiple dose administration
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Immunogenicity
Incidence of detectable anti-CDR404 antibodies (ADAs)
Measured: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start24 May 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Select Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- IV dose escalation
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CDR-Life AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402201
- Sponsor's protocol ID
- CDR404-001
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06402201
- Acronym / sponsor ID
- CDR404-001
- Conditions
- Select Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- CDR-Life AGIndustry (pharma, biotech, devices)
- Study start
- 24 May 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To identify the maximum tolerated dose (MTD) and pharmacologically effective dose range (PEDR) for CDR404
- To assess preliminary evidence of anti-tumor activity of CDR404
- To characterise the pharmacokinetics of CDR404
- To characterise the immunogenicity of CDR404
- To assess translational biomarkers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- IV dose escalation
| Arm | Type | Receives |
|---|---|---|
| CDR404 | Experimental | Biological: CDR404Dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of written informed consent
- HLA-A*02:01 positive
- MAGE-A4 positive tumor
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1
- Selected advanced solid tumors
Key exclusion criteria (13 listed)
- Symptomatic or untreated central nervous system metastasis
- Inadequate washout from prior anticancer therapy
- Significant ongoing toxicity from prior anticancer treatment
- Recent surgery
- Clinically significant cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDR404IV infusions | Biological | CDR404 |
Primary outcome
Presence of dose limiting toxicities (DLTs)
Time frame: From first dose to DLT period (21 days)
per Protocol
Incidence and severity of (serious) adverse events ([S]AEs)
Time frame: From first dose to 90 days after the last dose
AEs, SAEs
Anti-tumor response: Overall Response Rate (ORR)
Time frame: 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
14 secondary outcomes
Disease control rate (DCR)
Time frame: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Duration of response (DOR)
Time frame: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Progression-free Survival (PFS)
Time frame: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Overall Survival (OS)
Time frame: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Maximum serum concentration of CDR404 (Cmax)
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Time to maximum serum concentration of CDR404 (Tmax)
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Trough serum concentration of CDR404 (Ctrough)
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Half-life of CDR404 (t1/2)
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Area under the CDR404 serum concentration over time curve (AUC0-T)
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Volume of CDR404 distribution (Vd)
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Average serum concentration of CDR404 (Cavg)
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Serum drug levels of CDR404 at steady state (CL)
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Accumulation ratio of CDR404 (Rac)
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Immunogenicity
Time frame: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dimitrios Chondros Chief Medical Officer, CDR-Life contact
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDR404 in people with Select Advanced Solid Tumors, run by CDR-Life AG at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, United States, Belgium, United Kingdom, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios Chondros Chief Medical Officer, CDR-Life (+41 44 515 7025, CDR404-001_Study@CDR-Life.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of dose limiting toxicities (DLTs) (time frame: From first dose to DLT period (21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.