A Study of HQP1351 in Patients With GIST or Other Solid Tumors

Exclusion Criteria

• •1. Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days or 5 times half- time before first dose of HQP1351.
• •2. Received any TKIs within 14 days before first dose of HQP1351.
• •3. Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.
• •4. Have not recovered (\> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.
• •5. Malabsorption syndrome or other diseases that affect the absorption of oral drugs.
• •6. Cardiovascular diseases of clinical significance, uncontrollable or active, including but not limited to: history of myocardial infarction; unstable history of angina pectoris; a history of congestive heart failure or lower left ventricular ejection fraction (LVEF) than normal limit within 6 months; the history of atrial arrhythmias was judged by the researchers to have important clinical significance; history of ventricular arrhythmias, etc.
• •7. Hypertension was still poorly controlled after medication treatment (SBP \> 140 mmHg and/or DBP \> 90 mmHg).
• •8. Concurrent use any medication led to prolong QT interval.
• •9. Pulmonary mean arterial pressure\>35 mmHg by ECHO.
• •10. Significant severe cardiovascular conditions during previous TKI treatment.
• •11. Uncontrollable hypertriglyceridemia.
• •12. Performed major surgery (except for intravenous catheterization or bone marrow biopsy) within 14 days of first dose of HQP1351.
• •13. Arterial thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, TIA), or venous thrombosis events or pulmonary embolism within 6 months before the first dose of HQP1351 or deep vein thrombosis within 3 months before the first dose of HQP1351.
• •14. Brain metastasis.
• •15. Had other primary malignant tumors in the last three years (exception of the tumors being cured for 5 years or more, or complete removal of non-melanoma skin cancer or successful treatment of carcinoma in situ, or the controlled prostate cancer).
• •16. Had active, symptomatic infections (including known infections of HIV, viral hepatitis (A, B, or C)). If there is no history of infection, screening is not required.
• •17. Subjects who are known to be allergic to pharmaceutical ingredients or their analogs.
• •18. Pregnancy or lactation, or expect to be pregnant during the study period.
• •19. According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may jeopardize the safety or safety assessment of the subject.
• •20. Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.