Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer

Inclusion Criteria:

Histologically or cytologically confirmed colorectal adenocarcinoma.
Stage IV (metastatic) disease.
Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer.
Adequate performance status (Eastern Cooperative Oncology Group (ECOG) 0 or 1).
Expected survival > 6 months.
Carcinoembryonic antigen (CEA) plasma levels > 5 ng/mL.
Measurable disease by computed tomography (CT) or Magnetic resonance imaging (MRI).
At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities.
At least 2 weeks beyond corticosteroids.
Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
Otherwise, all toxicity at study entry ≤ Grade 1 by National cancer institute common terminology criteria for adverse events (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.
Individuals with Gilbert's disease or known central nervous system (CNS) metastatic disease.
Individuals with CEA plasma levels > 1000 ng/mL must be approved in advance by the Sponsor.
Presence of bulky disease (defined as any single mass > 10 cm in its greatest dimension).
Individuals with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
Individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while individuals with other prior malignancies must have had at least a 3-year disease-free interval.
Individuals known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
Known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
Known history of clinically significant active chronic obstructive pulmonary disease (COPD), or other moderate-to-severe chronic respiratory illness present within 6 months.
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.