Clinical trial · Interventional
First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Select Advanced Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDR404 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CDR404
- description
- Dose escalation
- interventionNames
- Biological: CDR404
Primary outcomes (3)
- measure
- Presence of dose limiting toxicities (DLTs)
- timeFrame
- From first dose to DLT period (21 days)
- description
- per Protocol
- measure
- Incidence and severity of (serious) adverse events ([S]AEs)
- timeFrame
- From first dose to 90 days after the last dose
- description
- AEs, SAEs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available