Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer

Inclusion Criteria:

- Have histologically confirmed colorectal cancer that is metastatic with measurable
disease.

- For the Phase II portion: Have recurred or progressed within 6 months of the last
cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic
colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin
because of intolerable toxicity are also eligible.

- At least 4 weeks have elapsed since the last chemotherapy, radiotherapy,
immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in
the case of nitrosourea and mitomycin).

- Have not received any other investigational agents within 4 weeks of study entry and
have fully recovered from any adverse event due to prior therapy.

- At least 4 weeks have elapsed since any major surgery.

- Have ECOG performance status of 0, 1, or 2.

- Have adequate bone marrow and organ function

Exclusion Criteria:

- Have an active, uncontrolled infection.

- Have known HIV positive status.

- Have known or suspected cerebral metastasis.

- Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the
last 6 months; or meet the criteria for AHA class III or IV congestive heart failure
(CHF).

- Have a medical condition requiring chronic use of high-dose corticosteroids or other
chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).

- Have a history of greater than or equal to Grade 2 allergic reaction or
hypersensitivity following exposure to humanized or human monoclonal antibodies (but
not chimeric antibodies).

- Pregnant or breastfeeding women and male or female patients who do not agree to use
effective contraceptive method(s) during the study.