NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

Exclusion Criteria

• •1. Prior systemic chemo-, radiochemo-, radio-, immuno-, hormonal and/or biological therapy within 2 weeks before study participation (in case of nitrosoureas and/or mitomycin, within 6 weeks before study participation)
• •2. Patients who received major surgery within 4 weeks before study participation (in case of VATS and/or ONC surgery, within 2 weeks before study participation)
• •3. Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.)
• •4. NYHA class III or IV heart failure, uncontrolled hypertension (SBP/DBP \> 140/90 mm Hg), other clinically significant cardiovascular abnormalities at investigator's discretion (e.g., LVEF \< 50%, clinically significant cardiac wall abnormalities or cardiac muscle damages)
• •5. Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months
• •6. Uncontrolled arrhythmia
• •7. Significant cerebrovascular diseases including stroke within 6 months
• •8. Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases
• •9. Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease
• •10. Patients who cannot receive IP by mouth and have a history of clinically significant gastrointestinal disorders which can impede administration, transit or absorption of the IP
• •11. A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP
• •12. Pregnancy or breast-feeding
• •13. Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
• •14. Patients who received other investigational products or used other investigational devices within 3 weeks before participation
• •15. Patients who cannot participate in this trial by investigator's discretion