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First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06402201.
Locations matching your search criteria
United States
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
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:
1. To identify the maximum tolerated dose (MTD) and pharmacologically effective dose
range (PEDR) for CDR404
2. To assess preliminary evidence of anti-tumor activity of CDR404
