A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic RCC

Inclusion Criteria:

* Histologically or cytologically confirmed renal cell cancer.Patients must be diagnosed with advanced or metastatic disease,disease progressed to previous treatment .
* Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Toxicity recovered to NCI CTCAE v.4.03 Grade ≤1 from previous treatments (except alopecia)
* ECOG performance status (PS) 0 or 1
* Life expectancy of ≥ 12 weeks
* Adequate organ function
* Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion Criteria:

* Chemotherapy,radiotherapy,immunotherapy and targeted therapy less than 4 months prior to administration.
* Symptomatic, untreated or unstable central nervous system metastases
* Uncontrolled hypertension that require anti-hypertensive agents to control, or systolic blood pressure (BP) \>140mmHg or diastolic BP \>90 mmHg before the first administration (BP is the mean blood pressure of two measures that 1 hours interval or above)
* Doppler ultrasound evaluation：Left ventricular ejection fraction \< 50%
* Significantly clinical arrhythmia or symptomatic bradycardia, or male with QTCF \> 450 ms or female with QTCF \> 470 ms, or patients with a history of torsion or congenital QT prolonged syndrome long QT syndrome
* Certain factors that would preclude adequate absorption of CT053PTSA and gefitinib (eg. unable to swallow, chronic diarrhea, intestinal obstruction)
* Patients with evidence of bleeding tendency, including the following cases: gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above; or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator
* History of organ transplantation
* Any disease of the following bellowed within 12 months prior to administration: Myocardial infarction, severe angina, or unstable angina, coronary or peripheral artery bypass graft, congestive heart failure
* Pulmonary embolism or cerebrovascular events (including transient ischemic attack)within 6 months prior to administration
* Infection of HIV
* Patients with infection of HBV or HCV. Patients with positive of HBsAg or HBcAb,and HBV-DNA can be measured (\>500IU/ml). Patients with positive of anti-HCV,and HCV-RNA can be measured by PCR.
* Other malignancies within 5 years prior to enrollment, with the exception of carcinoma in situ of the cervix, basal or squamous cell skin cancer
* Pregnant or lactating woman
* Any other reason the investigator considers the patient is not suitable to participate in the study