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Clinical Trials in Italy / NCT06402201
Recruiting Phase 1

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

NCT06402201 · tracked via the Priya Life Science Italy tracker
Sponsor
CDR-Life AG
Phase
Phase 1
Started
2024-05-24
Last updated
2026-09-24

Condition(s) studied

Select Advanced Solid Tumors

Investigational drug(s) / intervention(s)

CDR404

CDR404: IV infusions

Study 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). 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Presence of dose limiting toxicities (DLTs) — From first dose to DLT period (21 days)
    per Protocol
  • Incidence and severity of (serious) adverse events ([S]AEs) — From first dose to 90 days after the last dose
    AEs, SAEs
  • Anti-tumor response: Overall Response Rate (ORR) — 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

Trial sites (20)

FacilityCityRegionStatus
University of Miami Miami Florida Withdrawn
University of Michigan Ann Arbor Michigan Withdrawn
Providence Cancer Institute Portland Oregon Recruiting
Pennsylvania Hospital Philadelphia Pennsylvania Recruiting
Universitair Ziekenhuis Antwerpen Antwerp Belgium Recruiting
Institut Jules Bordet Brussels Belgium Recruiting
Cliniques Universitaires Saint-Luc, UCL Ouvain Brussels Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Istituto Clinico Humanitas Milan Italy Recruiting
Isituto Europeo di Oncologia (IEO) Milan Italy Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Recruiting
Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO) Barcelona Spain Recruiting
Hospital 12 de Octubre Madrid Spain Recruiting
START Madrid Madrid Spain Recruiting
Hospital Universitari i Politecnic La Fe Valencia Spain Recruiting
Instituto de Investigacion Sanitaria (INCLIVA) Valencia Spain Recruiting
Royal Marsden Hospital Sutton London Recruiting
The Beatson West of Scotland Cancer Center Glasgow United Kingdom Recruiting
Guys and St Thomas' NHS Foundation Trust London United Kingdom Not Yet Recruiting

Other trials for the same condition

Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06402201 on ClinicalTrials.gov ↗ ← All trials in Italy