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NCT Number: NCT06402201

First in Human Study 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.

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Key information

Conditions

Select Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitair Ziekenhuis Antwerpen, Antwerp, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Measurable disease per RECIST v1.1
  • Adequate organ function
  • If applicable, must agree to use highly effective contraception

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

CDR404

Biological

IV infusions

Primary outcomes

  1. Presence of dose limiting toxicities (DLTs)

    Time frame: From first dose to DLT period (21 days)

    per Protocol

  2. Incidence and severity of (serious) adverse events ([S]AEs)

    Time frame: From first dose to 90 days after the last dose

    AEs, SAEs

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitrios Chondros Chief Medical Officer, CDR-Life

CONTACT

[email protected]

+41 44 515 7025

Sponsors and collaborators

Lead sponsor

CDR-Life AG

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 7, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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