Phase 1, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors

You may not qualify if:

• Previously treated with any other agent that targets CD40;
• Concurrent treatment with any anticancer agent;
• History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory boweldisease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
• Treatment with any other investigational therapy within 4 weeks prior to baseline;
• History (within the previous year) of congestive heart failure, stroke, or myocardial infarction;
• Patients with known hereditary or acquired coagulopathies (eg. hemophilia, von Willebrand's disease, cancer-associated DIC, abnormal D-dimer);
• Patients with known brain metastases. Patients with clinical evidence suggestive of new brain metastases prior to enrollment are excluded if brain metastases have not been ruled out via CT or MRI. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable;
• Patients having reproductive potential who are not using an effective method of birth control or who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test during baseline;
• Known sensitivity to immunomodulating agents or monoclonal antibodies;
• Alcohol abuse or illicit drug use within 12 months of enrollment;
• History of serum creatinine ≥2 mg/dL for any duration and for any reason;
• Patients, other than menstruating females, with urine dipstick 1+ or more positive for blood or 2+ or more positive for protein;
• Patients with clinically significant presence of granular or cellular casts in centrifuged urine sediment;
• Patients with renal carcinoma or renal metastases;
• Patients that have had a partial or complete nephrectomy;
• +11 more criteria