A Phase I Trial of Simmitinib in Advanced Solid Tumors

Inclusion Criteria:

* Voluntary written informed consent of the patient obtained before any study-specific procedure；
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
* Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to standard therapy or for whom no standard therapy exist;
* Adequate washing period from last anti-tumor therapy;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
* The expected survival time for more than 12 weeks;
* Adequate bone marrow, hepatic, renal, pancreas, and coagulation function, Blood phosphorus and calcium in the normal range.

Exclusion Criteria:

* Prior treatment with selective FGFR inhibitors or multi-target kinase Inhibitors with FGFR as the main target;
* Unrecovered from any drug-related adverse event to grade ≤ 1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0 derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects;
* Active Central Nervous System (CNS) metastases (brain or leptomeningeal metastases, etc.);
* Any other history of malignancy within 3 years;
* Congenital coagulation abnormalities. Active bleeding or previous history of massive bleeding (\>30ml within 3 months), history of hemoptysis (more than 5ml fresh bleeding within 4 weeks);
* Corneal diseases of clinical significance. There is a history of retinal pigment epithelial detachment or evidence of the presence of retinal pigment epithelial detachment. History of age-related macular degeneration or evidence of age-related macular degeneration exists；
* Subjects with impaired cardiac function or heart disease of clinical significance;
* Pregnant or lactating women.