A Study of SHR6390 in Advanced Solid Tumor Patients

Inclusion Criteria:

* Pathologically confirmed solid tumor and failed from all standard treatment
* Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
* Life expectancy ≥ 3 months
* Adequate function of major organs, meaning the following criteria should be met within 14 days before randomization:

  * Hemoglobin \> 110g/L
  * Neutrophils \> 2.0×10\^9/L
  * Platelets \> 100×10\^9/L
  * Total bilirubin \< 1.5×the upper limit of normal (ULN)
  * ALT and AST ≤ 1.5×ULN (≤ 5×ULN, if existing liver metastases)
  * Creatinine ≤ 1 ULN
  * Left ventricular ejection fraction (LVEF) ≥ 50%
  * QTcF(Fridericia correction) male≤450 ms, female≤470 ms
* Good compliance of patient by physician's judgement
* Signed and dated informed consent

Exclusion Criteria:

* Previously received therapy of anti-tumor agent targeting at CDK4/6
* Less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy
* Less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy)
* Having joined in other clinical trials within 4 weeks
* Uncontrolled/untreated brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed)
* existing abnormal CTCAE≥grade 2 resulted from previous treatment(except grade 2 alopecia)
* uncontrollable symptomatic pleural effusion or ascites or require clinical intervention
* require continous treatment by steroids
* Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.)
* existing uncontrollable hypokalemia or hypomagnesemia
* history of serious allergy events or known being allergy constitution
* active HBV or HCV infection (HBV virus≥10e4 copies/ml, HCV virus≥10e3 copies/ml)
* History of immunodeficiency, acquired or congenital immunodeficiency, history of organ transplantation
* history of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥grade 2 found in screening
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test childbearing female who refuse to accept any contraception practice
* determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,etc.)
* history of neuropathy or dysphrenia, including epilepsy and dementia