A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma

Inclusion Criteria: Male or female from 18 to 75 year-old Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma whose standard treatment failed or proven unavailable or intolerant Has at least one non-CNS target lesion per RESIST v1.1 Has an Eastern Cooperative Oncology Group performance status of 0-1 Has a life expectancy of ≥ 12 weeks Should use adequate contraceptive measures throughout the study Females subject must not be pregnant at screening Has the ability to understand and willingness to sign a written informed consent before the performance of the study Exclusion Criteria: Received or being received treatment as follows: Hypoxia-induced factor inhibitors Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment. Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment. Major surgery within 4 weeks prior to the first dose of study treatment. Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy Has another malignancy or a history of another malignancy Has inadequate bone marrow reserve or organ dysfunction Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment Has severe infections within 4 weeks prior to the first dose of study treatment Has digestive system diseases may influencing ADME of study drug Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolics Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision