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

February 26, 2026 updated by: CDR-Life AG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
        • Principal Investigator:
          • Hans Prenen, MD
        • Contact:
      • Brussels, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
        • Principal Investigator:
          • Nuria Kotecki, MD
        • Contact:
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc, UCL Ouvain
        • Contact:
        • Principal Investigator:
          • Jean-Pascal Machiels, MD
      • Ghent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Principal Investigator:
          • Sylvie Rottey, MD
        • Contact:
  • Denmark
  • Italy
      • Milan, Italy, 20089
      • Milan, Italy, 20141
        • Recruiting
        • Isituto Europeo di Oncologia (IEO)
        • Contact:
        • Principal Investigator:
          • Guiseppe Curigliano, MD
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Alberto Hernando Calvo, MD
      • Barcelona, Spain, 08908
        • Recruiting
        • Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)
        • Contact:
        • Principal Investigator:
          • Ramon Salazar MD Martin, MD
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital 12 de Octubre
        • Contact:
        • Contact:
          • Sandra de la Llave, Marta Gutierrez, Elisa Lorente, Lidia Silvo, Veronica Silva
        • Principal Investigator:
          • Guillermo de Velasco, MD
      • Madrid, Spain, 28050
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politècnic La Fe
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillermo Suay Montagud, MD
      • Valencia, Spain, 46026
        • Recruiting
        • Instituto de Investigacion Sanitaria (INCLIVA)
        • Contact:
        • Contact:
          • Inma Blasco
        • Principal Investigator:
          • Desamparados Roda Perez, MD
  • United Kingdom
    • London
      • Sutton, London, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
        • Contact:
        • Principal Investigator:
          • Alec MD Paschalis
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Coral Olazagasti, MD
        • Contact:
        • Contact:
          • Phone Number: +1-305-243-7590
        • Sub-Investigator:
          • Gilberto de Lima Lopes, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Paul Swiecicki, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Institute
        • Principal Investigator:
          • Rom Leidner, MD
        • Contact:
        • Contact:
          • Phone Number: +1-503-215-5763
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Recruiting
        • Pennsylvania Hospital
        • Principal Investigator:
          • Mark Diamond, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CDR404
Dose escalation
Biological: CDR404
IV infusions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence of dose limiting toxicities (DLTs)
Time Frame: From first dose to DLT period (21 days)
per Protocol
From first dose to DLT period (21 days)
Incidence and severity of (serious) adverse events ([S]AEs)
Time Frame: From first dose to 90 days after the last dose
AEs, SAEs
From first dose to 90 days after the last dose
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
per RECIST 1.1
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
per RECIST 1.1
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
per RECIST 1.1
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
per RECIST 1.1
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)
following single and multiple dose administration
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)
following single and multiple dose administration
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)
following single and multiple dose administration
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)
following single and multiple dose administration
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)
to the end of the dosing interval following single and multiple dose administration
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)
following single and multiple dose administration
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)
following single and multiple dose administration
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)
following single and multiple dose administration
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)
following single and multiple dose administration
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
Incidence of detectable anti-CDR404 antibodies (ADAs)
From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CDR-Life AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDR404-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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