Phase 1 Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Solid Tumors

Exclusion Criteria

• •Known brain tumors or Central nervous system (CNS) metastases
• •Myocardial infarction within 6 months of anti-MIF antibody administration, congestive heart failure (New York Heart Association Class III or Class IV), unstable angina, unstable cardiac arrhythmia requiring medication, or risk factors for polymorphic ventricular tachycardia
• •Uncontrolled hypertension
• •Left ventricular ejection fraction (LVEF) \<40%, as determined by screening echocardiogram (echocardiogram results obtained within 90 days prior to screening are acceptable)
• •QT/QTc interval \>450 msec, as determined by screening electrocardiogram (ECG)
• •Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, or hormonal therapy) within 4 weeks prior to administration of the investigational product (IP) (6 weeks for nitrosoureas and mitomycin C). Any previous treatment-related toxicities must have recovered to Grade ≤ 1 (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03). Prior and concurrent use of hormone deprivation therapies for hormone-refractory prostate cancer or breast cancer are permitted.
• •Major surgery within 4 weeks prior to IP administration
• •Active joint inflammation or history of inflammatory arthritis or other immune disorder involving the joints
• •Active infection requiring IV antibiotics within 2 weeks prior to screening
• •Known history of hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis. Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease.
• •Participant has received a live vaccine within 4 weeks prior to screening
• •Known hypersensitivity to any component of recombinant protein production by Chinese Hamster Ovary (CHO) cells
• •Participant has been exposed to an investigational product (IP) or investigational device in another clinical study within 4 weeks prior to IP administration, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
• •Participant is nursing or intends to begin nursing during the course of the study
• •Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s), that in medical judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study
• •Participant is a family member or employee of the investigator