Perlmutter Cancer Center

This is an open-label, non-randomized, multicenter, dose-escalation study with expansion cohorts to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and clinical activity of CDX-585 in patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy. CDX-585 will be administered intravenously every 2 weeks until confirmed disease progression, intolerance, or for a maximum of 2 years. Doseescalation will be governed by specific rules outlined in the protocol until the highest per protocol dose level is studied or the MTD is identified. Post-treatment, patients will have an End of Treatment visit ideally 30 days (+ 5 days) after the last dose of study treatment (but may be done earlier, if necessary, due to planned initiation of alternate therapies) and a Safety Followup visit 90 days after the last dose of study treatment. Patients with CDX-585 related adverse event(s) should be followed until the event(s) resolve to baseline or Grade 1, or initiation of alternate anticancer therapy. Following the End of Treatment visit, patients will be followed at 12 (± 2) week intervals until death or for one year, for determination of survival status, subsequent therapies received and response to those therapies. For patients who discontinue treatment in the absence of progression, tumor response assessments should continue