NCT06402201 First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
| NCT ID | NCT06402201 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | CDR-Life AG |
| Condition | Select Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2024-05-24 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Dimitrios Chondros Chief Medical Officer, CDR-Life
✉ CDR404-001_Study@CDR-Life.com📞 +41 44 515 7025
Frequently Asked Questions
Who can join the NCT06402201 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Select Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06402201 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06402201 currently recruiting?
Yes, NCT06402201 is actively recruiting participants. Contact the research team at CDR404-001_Study@CDR-Life.com for enrollment information.
Where is the NCT06402201 trial being conducted?
This trial is being conducted at Miami, United States, Ann Arbor, United States, Portland, United States, Philadelphia, United States and 11 additional locations.
Who is sponsoring the NCT06402201 clinical trial?
NCT06402201 is sponsored by CDR-Life AG. The trial plans to enroll 42 participants.