NCT06553339 A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
| NCT ID | NCT06553339 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Condition | Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-07-19 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Kan Gong, PhD
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT06553339 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06553339 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06553339 currently recruiting?
Yes, NCT06553339 is actively recruiting participants. Contact the research team at kan.gong@bjmu.edu.cn for enrollment information.
Where is the NCT06553339 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06553339 clinical trial?
NCT06553339 is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. The principal investigator is Kan Gong, PhD at Peking University First Hospital. The trial plans to enroll 60 participants.