Study of rSIFN-co for Patients With Advanced Solid Tumors

Exclusion Criteria

• •1. Chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery within 4 weeks prior to first dose of study drug.
• •2. Prior mTOR inhibitor therapy within 4 weeks prior to first dose of study drug.
• •3. Has a history of autoimmune disorders, including uncontrolled diabetes ("uncontrolled" defined as Hemoglobin A1c ≥ 9% in 28 days prior to study).
• •4. Chronic use of steroid therapy.
• •5. Has a history of epilepsy, depression or other psychiatric disorders.
• •6. Has a history of an arterial thromboembolic event within the prior six months including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina.
• •7. Has uncontrolled human immunodeficiency virus (HIV) (defined as HIV RNA \>500 copies/ml and CD4+ count\<200/mm³ on antiretroviral therapy)infection, or hepatitis B (defined as ALT \> 1 x ULN, and HBV DNA \>2000 IU/ml), or hepatitis C (defined as ALT \> 1 x ULN, persistent viremia on antiviral therapy) infections.
• •8. Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment (patient must be on stable dose for 2 weeks).
• •9. Prior allogeneic bone marrow or organ transplantation.
• •10. Has any clinically significant infection, i.e., any acute viral, bacterial, or fungal infection that requires specific treatment (anti-infective treatment has to be completed ≥ 7 days prior to study entry).
• •11. Has any other severe, uncontrolled medical condition, including unstable congestive heart failure (Stage III-IV of the New York Heart Association Functional Classification) or has a known or suspected allergy to the study drug or any study drug component.
• •12. Pregnant or breastfeeding - interferon products (e.g., Infergen®) is Pregnancy Category C, (i.e., animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans.). Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• •13. Subject has received other investigational drugs within 14 days prior to first dose of study drug.
• •14. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study.
• •15. Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval \> 480 milliseconds).
• •16. Presence of any non-healing wound, fracture, or ulcer within 28 days prior to the first dose of study drug.
• •17. Has any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.
• •18. Has any mental or medical condition that prevents the subject from giving informed consent or participating in the trial