Trial Information

Summary: A Phase I Trial of CVX-060, an Anti-Angiogenic COVX-BODY in Patients with Advanced Solid Tumors

The purpose of this study is to determine the highest dose of CVX-060 that can be given by intravenous infusion weekly to patients with advanced solid tumor malignancies without unacceptable toxicity. Patients will be followed for the effect of the drug in terms of side effects, how it affects their disease, and pharmacokinetic testing. Pharmacokinetics (PKs) is a method to determine the levels of a drug in the blood and see how the body absorbs, distributes, metabolizes and eliminates it. This is done by frequent blood draws on key days during the first four weeks of treatment.

CVX-060 is a recombinant humanized monoclonal antibody that works by inhibiting new blood vessel growth to tumors (angiogenesis). It is believed that through the process of angiogenesis, tumors are able to grow and spread. CVX-060 is not FDA-approved and its use in this study is investigational.

Patient Inclusion Criteria:

• The first 2 cohorts will allow patients with measurable disease
• Starting with cohort 3 patients must have a measurable lesion outside the thoracic cavity amenable to MRI
• < 500 mg urinary protein/24 hours or dipstick < 2+
• BP of < 150/90
• Adequate liver, kidney, and bone marrow function

Patient Exclusion Criteria:

• Prior treatment with CVX-045
• Bleeding diathesis or coagulopathy
• History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months
• Anticoagulant therapy

If you would like to learn more about participating in this study, please send an e-mail message using the form below.