First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

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.