Phase I Study of HL-085 in Patients With Advanced Solid Tumors

Exclusion Criteria

• •1. Have undergone or plan to have major surgery or experienced severe trauma ≤28 days prior to starting the study treatment.
• •2. Known hypersensitivity to IP ingredients or their analogues.
• •3. Prior therapy with a MEK-inhibitor
• •4. Receipt of any other investigational agent therapy within 4 weeks prior to starting study treatment.
• •5. Any concurrent therapy for cancer treatment.
• •6. Have active central nervous system lesion.
• •7. Receiving and unable to discontinue medication which are strong inducers, strong inhibitors or enzyme substrates of cytochrome P450 CYP2C9 and CYP2C19 from 14 days prior to treatment.
• •8. Grade 3 bleeding symptoms (NCI-CTCAE v5.0) within 4 weeks prior to starting study treatment.
• •9. Unable to swallow IP or has refractory nausea and vomiting, malabsorption, external biliary diversion, or any significant small bowel resection that may interfere with adequate absorption of IP.
• •10. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome.
• •11. Left ventricular ejection fraction (LVEF) \<50%.
• •12. History major cerebrovascular diseases within 6 months prior to enrollment.
• •13. Infectious diseases requiring systemic treatment.
• •14. History or current evidence of retinal diseases.
• •15. Have active/chronic infection with hepatitis C, or positive hepatitis B surface antigen (HBsAg), or active/chronic infection with human immunodeficiency virus (HIV).
• •16. Known active tuberculosis.
• •17. History of allogeneic bone marrow transplantation or organ transplantation.
• •18. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
• •19. Pregnant or breast-feeding females.
• •20. Previous or history of second malignancy within 5 years prior to study treatment
• •21. Other conditions which may increase the risk associated with study participation, or interfere with the evaluation of study results.