Study of IMMU-130 in Patients With Relapsed/Refractory Colorectal Cancer

Inclusion criteria

• Male or female patients, >18 years of age, able to understand and give written informed consent.
• Histologically or cytologically confirmed colorectal adenocarcinoma.
• Stage IV (metastatic) disease.
• Failed at least one prior standard treatment regimen for colorectal cancer
• Adequate performance status (ECOG 0 or 1)
• Expected survival > 6 months.
• CEA plasma levels > 5 ng/mL
• Measurable disease by CT or MRI
• At least 4 weeks beyond major surgery and recovered from all acute toxicities
• At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis
• Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3)
• Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
• Otherwise, all toxicity at study entry <Grade 1 by NCI CTC v4.0.

Exclusion criteria

• Women who are pregnant or lactating.
• Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
• Patient's with Gilbert's disease or known CNS Metastatic disease. However, patients with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new enlarging CNS metastasis (2) off steroids or on a stable dose of steroids
• Patients with CEA plasma level > 1000 ng/mL are excluded during dose escalation, but may be included after the MTD is determined
• Patients with active grade 3 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
• Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 3-year disease free interval.
• Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
• Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy,
• Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
• Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids, and other than diabetes, vitiligo, or stable thyroid disease).
• Infection requiring intravenous antibiotic use within 1 week.
• Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.