A Study of CDX-585 in Patients With Advanced Malignancies

Inclusion Criteria

• Recurrent, locally advanced, or metastatic solid tumor cancer excluding primary central nervous system tumors (e.g., glioblastoma).
• Receipt of standard therapy for the tumor type in the recurrent, locally advanced, or metastatic setting.
• Measurable (target) disease by iRECIST.
• If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment.
• Willingness to undergo a pre-treatment and on-treatment biopsy, if required. Key

Exclusion Criteria

• History of severe hypersensitivity reactions to other monoclonal antibodies.
• Previous treatment with any anti-ILT4 antibody.
• Patients who have received more than 1 anti-PD-1 or anti-PD-L1 targeted therapy, including in the adjuvant setting.
• Prior anti-PD-L1 based therapy within 12 weeks and prior anti-PD-1 based therapy within four weeks to the planned start of study treatment.
• Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least one year to be allowed to enroll.
• Thrombotic events within the last six months prior to study treatment
• Active, untreated central nervous system metastases.
• Active autoimmune disease or documented history of autoimmune disease.
• History of (non-infectious) pneumonitis or has current pneumonitis. There are additional criteria your study doctor will review with you to confirm eligibility.