Actively Recruiting
A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2024-08-14
60
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years
- Patients with advanced clear cell renal cell carcinoma or Von Hippel-Lindau Syndrome associated tumors
- Eastern Cooperative Oncology Group performance status of 0-1
- Life expectancy of at least 12 weeks
- Use adequate contraceptive measures throughout the study
- Female subjects must not be pregnant at screening
- Ability to understand and sign written informed consent before study participation
You will not qualify if you...
- Received hypoxia-induced factor inhibitors
- Used traditional Chinese medicine for tumors within 2 weeks before first study dose
- Received cytotoxic chemotherapy, investigational drugs, or systemic anti-tumor therapies within 3 weeks before first study dose
- Used colony-stimulating factors within 4 weeks before first study dose
- Had local radiotherapy within 2 weeks, or large-area bone marrow radiotherapy within 4 weeks before first study dose
- Underwent major surgery within 4 weeks before first study dose
- Pulse oximetry reading less than 92%, or requires supplemental oxygen
- Not recovered from grade 2 or higher adverse events from prior anti-tumor therapy
- Has another malignancy or history of non-VHL syndrome malignancy
- Inadequate bone marrow reserve or organ dysfunction
- Clinically significant bleeding or bleeding tendency within 1 month before first study dose
- Severe infections within 4 weeks before first study dose
- Digestive diseases affecting drug absorption, distribution, metabolism, or excretion
- History of severe allergic reaction or allergy to HS-10516 or its metabolites
- Any disease or condition compromising safety or study assessments per investigator's decision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
K
Kan Gong, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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