Trial Information

Summary: A Phase I Study of BIIB015 in Patients with Cripto-Positive Solid Tumors

The purpose of this study is to determine the safety and tolerability of BIIB015 when given intravenously to patients with advanced solid tumor malignancies whose tumors express Cripto. The study will assess the effects of this drug on patients and their cancers by assessing the patients' side effects and through pharmacokinetics. Pharmacokinetics (PKs) is a way to determine the amount of drug in the patient's blood and to see how the body processes, distributes, metabolizes and eliminates the drug. This is done by frequent blood draws during the first four weeks of treatment.

Patients who consent for the tissue procurement protocol will have archival tissue tested for Cripto expression. Cripto expression is required to participate in this study. BIIB015 is a humanized, IgG1, anti-Cripto, monoclonal antibody. It is not approved by the FDA and is therefore investigational in this trial.

Patient Inclusion Criteria:

• Archival tissue must be tested and express Cripto
• Evaluable disease allowed