NCT06553339RecruitingPhase 1
A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors，to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy
Source: ClinicalTrials.gov · Last updated 14 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 12 Aug 2024
- Start date
- 19 Jul 2024
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Diseases
- Kidney cancer
- NCT number
- NCT06553339
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 19 Jul 2024 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recieved or being received treatment as follows:
- Hypoxia-induced factor inhibitors
- Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
- Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment
- Colony-stimulating factors (CSFs) within 4 weeks before the first dose of study treatment
- 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.
- Major surgery within 4 weeks prior to the first dose of study treatment.
- Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy
- Has a clinically significant bleeding events or tendency within 1 month prior to the first dose of study treatment
- Has severe infections within 4 weeks prior to the first dose of study treatment
Other illness
- Has another malignancy or a history of another non-VHL syndrome associated malignancy
- Has digestive system diseases may influencing ADME of study drug
- Has a history of severe hypersensitivity reaction, or proven allergic to HS-10516 or its metabolin
- Has any disease or condition would compromise subject safety or interfere with study assessments by investigator's decision
Other
- Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- Has inadequate bone marrow reserve or organ dysfunction
Who the study is looking for
- Male or female from 18 to 80 year-old
- Patients with advanced clear cellrenal cell carcinoma or von Hippel-Lindau Syndrome associated tumors
- Has an Eastern Cooperative Oncology Group performance status of 0-1
- Has a life expectancy of ≥ 12 weeks
- Should use adequate contraceptive measures throughout the study
- Females subject must not be pregnant at screening
- Has the ability to understand and willingness to sign a written informed consent before the performance of the study.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.