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

September 21, 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

42

Phase

  • 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 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, 20141
        • Recruiting
        • Isituto Europeo di Oncologia (IEO)
        • Contact:
        • Principal Investigator:
          • Guiseppe Curigliano, MD
      • Milan, Italy, 20089
  • 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 Politecnic 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
      • Glasgow, United Kingdom
        • Recruiting
        • The Beatson West of Scotland Cancer Center
        • Principal Investigator:
          • Jeff Evans
        • Contact:
      • London, United Kingdom
        • Not yet recruiting
        • Guys and St Thomas' NHS Foundation Trust
        • Principal Investigator:
          • Rebecca Kristeleit
        • Contact:
    • 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
        • Withdrawn
        • University of Miami
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Withdrawn
        • University of Michigan
    • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
Experimental: CDR404

Dose escalation
Biological: CDR404

IV infusions

What is the study measuring?

Primary Outcome Measures

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

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

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)

May 24, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2026

Last Update Submitted That Met QC Criteria

September 21, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID 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

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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