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

Exclusion Criteria19

• Prior or Current Treatments:
• Previous or current use of hypoxia-inducible factor inhibitors.
• Previous or current use of lenvatinib.
• Use of Chinese herbal medicine with antitumor indications within 2 weeks prior to the first dose or requirement for such treatment during the study.
• 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.
• Use of large-molecule antitumor drugs within 4 weeks prior to the first dose or requirement for such treatment during the study.
• 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.
• 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.
• 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.
• 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).
• Resting pulse oximetry \<92% at screening.
• Severe pulmonary dysfunction requiring intermittent/long-term oxygen therapy.
• Unresolved Grade \>1 toxicities from prior anti-tumor therapy (per CTCAE v5.0).
• History of second primary malignancy.
• Known or suspected active CNS metastases/leptomeningeal disease.
• Inadequate bone marrow reserve or serious organ dysfunction.
• Severe, uncontrolled, or active cardiovascular disease.
• Severe or poorly controlled diabetes.
• Severe or poorly controlled hypertension.