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 (18)
Facility
City
Region
Status
University of Miami
Miami
Florida
Recruiting
University of Michigan
Ann Arbor
Michigan
Recruiting
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)
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.
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