Study of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma

Exclusion Criteria

• •1. Prior or Current Treatments:
• •1. Previous or current use of hypoxia-inducible factor inhibitors.
• •2. Previous or current use of lenvatinib.
• •3. Use of Chinese herbal medicine with antitumor indications within 2 weeks prior to the first dose or requirement for such treatment during the study.
• •4. Administration of cytotoxic chemotherapy or other systemic antitumor therapies (e.g., endocrine therapy, molecular targeted therapy) within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose, or requirement for such treatments during the study.
• •5. Use of large-molecule antitumor drugs within 4 weeks prior to the first dose or requirement for such treatment during the study.
• •6. Use of CYP2C19 strong inhibitors/inducers or narrow therapeutic index sensitive substrates within 7 days prior to the first dose, or requirement for continued use during the study.
• •7. Local radiotherapy (except brain radiotherapy; see Criterion 6) within 2 weeks prior to the first dose, or \>30% bone marrow irradiation/large-field radiotherapy within 4 weeks prior to the first dose.
• •8. Major surgery (e.g., craniotomy, thoracotomy, laparotomy; Grade 3/4 per Chinese Medical Technical Clinical Application Regulations) within 4 weeks prior to the first dose.
• •9. Participation in other interventional clinical trials within 4 weeks prior to the first dose or within 5 half-lives of investigational drugs (whichever is longer).
• •2. Resting pulse oximetry \<92% at screening.
• •3. Severe pulmonary dysfunction requiring intermittent/long-term oxygen therapy.
• •4. Unresolved Grade \>1 toxicities from prior anti-tumor therapy (per CTCAE v5.0).
• •5. History of second primary malignancy.
• •6. Known or suspected active CNS metastases/leptomeningeal disease.
• •7. Inadequate bone marrow reserve or serious organ dysfunction.
• •8. Severe, uncontrolled, or active cardiovascular disease.
• •9. Severe or poorly controlled diabetes.
• •10. Severe or poorly controlled hypertension.