Clinical Trial Finder

Inclusion Criteria:

1. Male or female from 18 to 80 year-old. 2. Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors. 3. Has an Eastern Cooperative Oncology Group performance status of 0-1. 4. Has a life expectancy of ≥ 12 weeks. 5. Should use adequate contraceptive measures throughout the study. 6. Females subject must not be pregnant at screening. 7. Has the ability to understand and willingness to sign a written informed consent before the performance of the study.

Exclusion Criteria:

1. Recieved or being received treatment as follows: 1. Hypoxia-induced factor inhibitors. 2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment. 3. Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment. 4. Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment. 5. 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. 6. Major surgery within 4 weeks prior to the first dose of study treatment. 2. Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen. 3. Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy. 4. Has another malignancy or a history of another non-VHL syndrome associated malignancy. 5. Has inadequate bone marrow reserve or organ dysfunction. 6. Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment. 7. Has severe infections within 4 weeks prior to the first dose of study treatment. 8. Has digestive system diseases may influencing ADME of study drug. 9. Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolin. 10. Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision

This is a Phase Ia/Ib open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with VHL Syndrome Associated Tumors. HS-10516 as a single agent, is administrated orally once daily. The aim of phase Ia, a dose escalation study, is to identify the MTD/MAD of HS-10516. The goal of Phase Ib, a dose expansion study, is to evaluate the safety, pharmacokinetics and antitumor efficacy of HS-10516.

Arms

Experimental: Phase Ia dose escalation arm

Participants will be assigned to pre-specified dose level to identify the MTD/MAD of HS-10516.

Experimental: Phase Ib dose expansion arm 1

Participants with VHL Syndrome associated RCC, whose lesions diameter ≤ 3 cm.

Experimental: Phase Ib dose expansion arm 2

Participants with VHL Syndrome associated RCC, who could not be included in arm 1.

Experimental: Phase Ib dose expansion arm 3

Participants with VHL Syndrome associated non-RCC tumors.

Interventions

Drug: - Oral HS-10516

Oral HIF-2α inhibitor