Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone

The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3mg/kg in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone. Approximately 168 patients are planned to be enrolled to this study.

Inclusion criteria

• Patient's age is 18 years or older, both genders.
• Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
• ECOG performance status ≤ 1
• At least 4 weeks from prior major surgery or radiotherapy.
• Life expectancy >3 months
• Hematology: ANC ≥ 1.5X109/L; Platelets >100x109/L.
• Adequate Renal function
• Adequate Hepatic functions
• Normal Cardiac function

Exclusion criteria

• Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
• Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.
• Patients on concurrent anti cancer therapy other than that allowed in the study.
• Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
• Presence of clinically apparent or suspected brain metastasis.
• Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
• Serious active infection at the time of pre-study screening.
• Active or history of autoimmune disorders/conditions.
• Women who are pregnant or lactating
• Concurrent active malignancy.
• Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
• Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
• Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
• Patients with history of life threatening allergic reactions to food or drugs
• Patients with symptomatic peripheral neuropathy> Grade 1.
• Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.