Overview
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.
Description
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:
- To identify the maximum tolerated dose (MTD) and pharmacologically effective dose range (PEDR) for CDR404
- To assess preliminary evidence of anti-tumor activity of CDR404
- To characterise the pharmacokinetics of CDR404
- To characterise the immunogenicity of CDR404
- To assess translational biomarkers
Eligibility
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.