A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours

Exclusion Criteria

• •Patients cannot participate in this clinical study if they meet any of the following conditions:
• •1. Pregnant or lactating women.
• •2. Tested positive for human immunodeficiency virus (HIV).
• •3. The active period of HBV or HCV infection is known to be associated with abnormal liver function, and antiviral drugs are required.
• •4. Severe trauma, ulcer or fracture at screening time.
• •5. A history of uncontrolled epilepsy, central nervous system disease or mental illness.
• •6. Symptomatic or uncontrolled brain metastases or meningeal diseases.
• •7. diabetes or hypertension with poor drug control (under optimal drug treatment, fasting blood glucose \>7mmol/L, or blood pressure \> 150/100mmhg).
• •8. Uncontrolled thyroid dysfunction.
• •9. Persistent arrhythmias of version 4.03 or above, NCI CTCAE level ≥2, atrial fibrillation of any level.
• •10. Cardiac ejection fraction (ECHOcardiography) below 50%.
• •11. patients with clinically significant prolonged history of QTc (\>450ms for male and \>470ms for female).
• •12. Have a history of severe drug allergy (NCI CTCAE level ≥3 according to version 4.03 or above) and may be allergic to test drug ingredients; Has been treated with or is allergic to sunitinib malate.
• •13. for the first time to give medicine taken within 4 weeks before have significant effects on P450 metabolic pathway of drugs (for example: ketoconazole, itraconazole, clarithromycin, aza that wei, indiana that wei, naphthalene sanzuotong, that of the wei and the wey, ShaKui the wey, terry toxin, voriconazole, dexamethasone, phenytoin, carbamazepine, rifampicin, dean, rifampicin and dean at the cloth, phenobarbital, st. John's wort, etc.) or to eat within 48 h before delivery of P450 metabolic enzyme pathways have a significant impact on food (such as grapefruit and food containing grapefruit).
• •14. Received any experimental drug therapy within 6 weeks prior to initial administration.
• •15. for the first time six weeks before the treatment, patients treated with anti-tumor therapy (chemotherapy, radiation therapy, biological therapy, or hormone therapy) (note: for anti-tumor small molecules targeting drugs, if the patient before the first test drugs, always use small molecules targeting drug has cleared more than 5 half-life, the patient may also be considered into the group\]. Surgery was performed within 14 weeks prior to the first administration.
• •16. patients have any limit test compliance of medical or psychiatric conditions, such as the central nervous system (CNS) leukemia, active control of bacterial infection, 3, or 4 bleeding, unstable angina, myocardial infarction, stroke or transient ischemic attack, pulmonary embolism, or into the group of six months before the test of catheter-related deep vein thrombosis, insulin-dependent diabetes mellitus (namely, type 1 diabetes), or non insulin-dependent diabetes but there were signs of small vascular disease, Adrenocortical dysfunction is known, malabsorption syndrome is known, and active autoimmune diseases are known.
• •17. Other severe acute or chronic medical or psychiatric conditions, or laboratory test abnormalities that may exacerbate the risks associated with participating in or taking test drugs, or that may interfere with the interpretation of test results. These conditions or abnormalities may be determined by the investigator to make the patient unfit to participate in the trial.