A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors

Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)

N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.

Inclusion criteria:

• Signed written informed consent
• Male and female patients > or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists
• Clinically or radiologically documented measurable disease.
• Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
• Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)

Exclusion criteria:

• Receipt of ADH-1 prior to this clinical study
• Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
• History of primary brain tumors or brain metastases
• History of spinal cord compression or tumors that have shown any evidence of active bleeding within 30 days before study entry.
• Stroke, major surgery, or other major tissue injury within 30 days before study entry
• History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states