Study of IMC-11F8 in Participants With Colorectal Cancer

Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer

The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).

The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants.

Inclusion Criteria:

• Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC
• Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum
• At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI); target lesion(s) must not lie within an irradiated area
• Age ≥18 years
• Life expectancy of ≥6 months
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at study entry
• Adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5 x 10^9 liter (L), hemoglobin ≥10 grams per deciliter (g/dL), and platelets ≥100 x 10^9/L
• Adequate hepatic function as defined by a total bilirubin ≤1.5 milligrams per deciliter (mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (or 5.0 x ULN in the case of liver metastases), and alkaline phosphatase (AP) ≤2.5 x ULN (or 5.0 x ULN in the case of liver metastases)
• Adequate renal function as defined by a serum creatinine ≤1.5 x ULN, creatinine clearance ≥ 60 milliliters per minute (mL/min), or serum albumin ≥lower limit of normal (LLN)
• Participant's relevant toxicities/effects of prior therapy [surgery/radiation therapy (RT)] must have recovered to a stable or chronic level
• Participant agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Participants must notify the principal investigator if they themselves or their partner becomes pregnant.
• Participant has provided signed Informed Consent

Exclusion Criteria:

• Has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC.
• Has received prior radiotherapy to >25% of bone marrow
• Has documented and/or symptomatic brain metastases
• Has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry
• Has received previous therapy with monoclonal antibodies
• Has received previous therapy with any agent that targets the EGFR
• Has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the participant or study.
• On chronic non-topical corticosteroid treatment for >6 months at doses >10 milligrams per day (mg/day) of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the participant or the study
• Has a known dihydropyrimidine dehydrogenase deficiency
• Has a known allergy to any of the treatment components
• Has an acute or subacute intestinal occlusion
• Has peripheral neuropathy ≥Grade 2
• Has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
• If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin test) or breast-feeding
• Has received a prior autologous or allogeneic organ or tissue transplantation
• Has interstitial pneumonia or interstitial fibrosis of the lung
• Has pleural effusion or ascites that causes ≥Grade 2 dyspnea
• Has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent