A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Aug 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HS-10516 for patients with tumors related to Von Hippel-Lindau (VHL) syndrome, specifically a type of kidney cancer known as clear cell renal cell carcinoma. The trial has two parts: the first part aims to find out the highest dose of HS-10516 that patients can safely receive, while the second part will look at how well the treatment works in patients with these tumors.

To participate, you need to be between 18 and 80 years old and have advanced kidney cancer or tumors associated with VHL syndrome. You should also be in relatively good health, meaning you can perform daily activities with little to no assistance. If you join the trial, you will receive HS-10516 and will be monitored closely by the medical team to check for any side effects and to see how well the treatment is working. It's important to note that certain recent treatments or health conditions may prevent you from participating, so discussing your medical history with the study team will be essential.

Gender

ALL

Eligibility criteria

• 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