A Study of CDX-585 in Patients With Advanced Malignancies
Non-small Cell Lung Cancer, Gastric Cancer, Head and Neck Cancer
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring LILRB2, CD85d, ILT-4, PD1, Bi-Specific, Immunotherapy, Solid tumor Malignancies, Dose escalation, Immunological
Eligibility Criteria
Key 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.
Sites / Locations
- George Washington University Cancer CenterRecruiting
- AdventHealth CelebrationRecruiting
- Perlmutter Cancer Center at NYU Langone HealthRecruiting
- Providence Cancer InstituteRecruiting
Arms of the Study
Arm 1
Experimental
CDX-585
Dose-escalation phase: Eligible patients will receive treatment, based on cohort assigned, in 2-week cycles until progression or intolerance. Expansion phase: Patients enrolled in the expansion phase of the study will receive CDX-585 at the dose level chosen during the escalation phase.