Tests HS-10516 with lenvatinib in advanced kidney cancer

Who can take part

• Men or women aged more than or equal to (≥) 18 years
• Histologically confirmed unresectable, locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) with disease progression during or after receiving ≥1 prior line of systemic therapy in the advanced setting
• Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required). Patients with only brain and/or bone lesions as target lesions will not be included
• ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
• Estimated life expectancy greater than (>) 12 weeks
• Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 12 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit
• Females must have the evidence of non-childbearing potential
• Sign informed consent form

Who cannot take part

• 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)
• 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
• Severe, uncontrolled, or active cardiovascular disease
• Severe or poorly controlled diabetes
• Severe or poorly controlled hypertension
• Resting pulse oximetry <92% at screening
• Inadequate bone marrow reserve or serious organ dysfunction