Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer

Exclusion Criteria

• •1. Known central nervous system metastases
• •2. Prior malignancy(s) within the past 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin, locally advanced prostate cancer, ductal carcinoma in situ of breast, in situ cervical carcinoma and superficial bladder cancer
• •3. Prior treatment with panitumumab for subjects with KRAS and NRAS wt tumor
• •4. Residual AE from previous treatment \> Grade 1
• •5. Prior intolerance to fluoropyrimidine for subjects with KRAS or NRAS mut tumor
• •6. Myocardial infarction within 6 months prior to C1D1, and/or prior diagnoses of congestive heart failure (New York Heart Association Class III or IV), unstable angina, unstable cardiac arrhythmia requiring medication; and/or the subject is at risk for polymorphic ventricular tachycardia (eg, hypokalemia, family history or long QT syndrome)
• •7. Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg confirmed upon repeated measures
• •8. LVEF \< 40% as determined by echocardiogram performed at screening or within 90 days prior to C1D1
• •9. QT/QTc interval \> 450 msec, as determined by screening ECG performed no earlier than 1 week before C1D1
• •10. Prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy or hormonal therapy) within 4 weeks prior to C1D1.
• •11. Major surgery within 4 weeks prior to C1D1
• •12. Active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints
• •13. Active infection involving IV antibiotics within 2 weeks prior to C1D1
• •14. Known history of, or active hepatitis B virus (HBV), hepatitis C virus (HCV) or active tuberculosis
• •15. Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease
• •16. Subject has received a live vaccine within 4 weeks prior to C1D1
• •17. Known hypersensitivity to any component of recombinant protein production by CHO cells
• •18. Exposure to an investigational product or investigational device in another clinical study within 4 weeks prior to C1D1, or is scheduled to participate in another clinical study involving an investigational product or device during the course of this study
• •19. Subject is nursing or intends to begin nursing during the course of the study
• •20. Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests, ECG), that in medical judgment of the investigator may impede the subject's participation in the study, pose increased risk to the subject, and/or confound the results of the study
• •21. Subject is a family member or employee of the investigator