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Clinical Trials in China / NCT06553339
Recruiting Phase 1

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

NCT06553339 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2024-07-19
Last updated
2024-08-14

Condition(s) studied

Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

Oral HS-10516

Oral HS-10516: Oral HIF-2α inhibitor

Study summary

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 patients with VHL Syndrome Associated Tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting

More Jiangsu Hansoh Pharmaceutical Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06553339 on ClinicalTrials.gov ↗ ← All trials in China