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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06553339
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kan Gong, PhD
Principal Investigator Affiliation	Peking University First Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma

Additional Details

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 & Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.