Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer

Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.

This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.

This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40; evaluated the immune response to the study treatment; measure the pharmacokinetics of anti-OX40; monitor tumor regression, and identify the most biologically active dose of anti-OX40 to induce antigen-specific responses to a variety of immunogens.

Inclusion Criteria:

• Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma.
• ECOG performance status 0, 1, 2
• No active bleeding
• No clinical coagulopathy
• Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

• Active residual toxicity from prior therapies
• Active Infection
• HIV positive
• Hepatitis B or C positive
• Pregnant or nursing women
• Requirement for oral steroids
• Brain metastases
• Presence or history of autoimmune disease
• Shellfish or tetanus allergy
• Splenomegaly
• Lymph nodes greater than 10 cm in maximal diameter
• Uncontrolled angina or class II or IV heart failure