Actively Recruiting
A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumors to Investigate Safety, Tolerance, Pharmacokinetic and Efficacy
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2024-08-14
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying HS-10516, an oral HIF-2b1 inhibitor, in Chinese patients aged 18 to 80 years who have Von Hippel Lindau (VHL) Syndrome associated tumors, including advanced clear cell renal cell carcinoma. The study aims to find the highest safe dose of HS-10516 in the Phase Ia dose escalation part and to evaluate its safety, how the body processes the drug, and its preliminary antitumor effects in Phase Ib. This open-label Phase I study is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. Participants receive HS-10516 once daily by mouth. In Phase Ia, patients are assigned to increasing dose levels to determine the maximum tolerated or acceptable dose. Phase Ib involves expanding patient groups based on tumor types and sizes, including those with VHL-associated renal cell carcinoma with lesions 64 3 cm, those with larger renal lesions, and those with non-renal tumors related to VHL syndrome. Each phase has specific treatment goals and dosing schedules. Throughout the study, participants undergo evaluations including safety monitoring, blood tests to assess drug levels, and tumor assessments reviewed by an independent committee. The primary outcomes include identifying the maximum tolerated dose in about two months and measuring tumor response over approximately one year. Secondary outcomes track adverse events, drug concentration over time, tumor control, progression-free and overall survival, with follow-up lasting up to two years. Participants must also use contraception and agree to informed consent before joining.
CONDITIONS
Brief 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
- Has an Eastern Cooperative Oncology Group performance status of 0-1
- Has a life expectancy of at least 12 weeks
- Agrees to use adequate contraceptive measures throughout the study
- Female participants must not be pregnant at screening
- Has the ability and willingness to provide written informed consent before study procedures
You will not qualify if you...
- Received or currently receiving hypoxia-induced factor inhibitors
- Used traditional Chinese medicine for tumors within 2 weeks before the first dose
- Received cytotoxic chemotherapy, investigational drugs, or other systemic anti-tumor therapies within 3 weeks before the first dose
- Taken colony-stimulating factors within 4 weeks before the first dose
- Had local radiotherapy within 2 weeks, or large-area bone marrow radiotherapy within 4 weeks before the first dose
- Undergone major surgery within 4 weeks before the first dose
- Has pulse oximetry reading less than 92%, or requires supplemental oxygen
- Not recovered from grade 2 or higher adverse event due to prior anti-tumor therapy
- Has other malignancies unrelated to VHL syndrome
- Has inadequate bone marrow or organ function
- Experienced significant bleeding within 1 month before the first dose
- Has severe infections within 4 weeks before the first dose
- Has digestive system diseases affecting drug absorption or metabolism
- Has history of severe allergic reaction or allergy to HS-10516 or its metabolites
- Has any condition that compromises safety or study assessments as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months for Phase Ia dose escalation; up to 1 year for Phase Ib dose expansion
Participants take oral HS-10516 once daily to assess safety, pharmacokinetics, and antitumor efficacy.
Regular visits during treatment period to monitor safety and response
Duration - Up to 2 years
Participants are monitored for longer-term safety and survival outcomes after completing treatment.
Periodic visits for monitoring adverse events and survival
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
K
Kan Gong, PhD
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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