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
CDR-Life AG
42 participants
May 24, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria13
- 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.
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Interventions
IV infusions
Locations(18)
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NCT06402201