A Phase Ia/Ib Study of HS-10516 to Investigate the Safety, Tolerance, Pharmacokinetic and Efficacy in Patients With Advanced Clear Cell Renal Cell Carcinoma

HS-10516-101

The aim of the Phase Ia portion is to identify the maximum tolerated dose or maximum acceptable dose MTD/MAD of HS-10516. The phase Ib portion will evaluate the preliminary efficacy of HS-10516 in ccRCC.

2023-09-25

2024-09-25

2025-09-25

Not yet recruiting

Early phase I

190

Inclusion Criteria: 1. Male or female from 18 to 75 year-old 2. Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma whose standard treatment failed or proven unavailable or intolerant 3. Has at least one non-CNS target lesion per RESIST v1.1 4. Has an Eastern Cooperative Oncology Group performance status of 0-1 5. Has a life expectancy of ≥ 12 weeks 6. Should use adequate contraceptive measures throughout the study 7. Females subject must not be pregnant at screening 8. Has the ability to understand and willingness to sign a written informed consent before the performance of the study Exclusion Criteria: 1. Received 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 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 metabolics 10. Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 190, 'type': 'ESTIMATED'}}

2023-09-26