Phase Ib/II Clinical Study of SHR-8068 Combined Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom

Prior treatment

• Have previously used or are currently using HIF inhibitors.
• Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
• Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
• Undergoing major surgical treatment within a certain period of time after the first administration of medication (excluding diagnosis) or expecting major surgical treatment during the study period.
• There are severe gastrointestinal function abnormalities in clinical practice, which may affect the intake, transportation or absorption of drugs.
• Patients who have received organ transplants in the past (excluding corneal transplants).
• A clinically significant thrombotic or embolic event occurred within 6 months prior to the first administration of the drug.
• The toxicity and/or complications of previous intervention measures have not been restored to the level of NCI-CTCAE≤1 or the inclusion and exclusion criteria.

Other illness

• Suffering from other active malignant tumors within 3 years or at the same time.
• There are clinical symptoms or diseases of the heart that are not well controlled.
• Active tuberculosis.
• Subjects with active hepatitis B or active hepatitis C.

Other

• Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion.
• As determined by the researcher, there are other factors that may affect the research results or lead to the forced termination of this study midway

• Age 18 to 75 years old (including boundary values)
• Volunteer to participate in this clinical study and sign informed consent;
• ECOG score 0-1;
• Expected survival ≥3 months;
• Patients with locally advanced unresectable or metastatic clear cell renal cell carcinoma confirmed by histology or cytology;
• Tumor tissue samples must be provided for testing
• There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
• Adequate bone marrow and organ function.