RecruitingPhase 1NCT06553339

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


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

60 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing HS-10516, a new oral drug that targets a protein called HIF (hypoxia-inducible factor), in patients with advanced kidney cancer (clear cell renal cell carcinoma) or tumors associated with von Hippel-Lindau (VHL) syndrome — a genetic condition that causes benign and cancerous tumors in the kidneys, brain, spine, and eyes. **You may be eligible if...** - You are 18–80 years old with advanced clear cell kidney cancer or VHL syndrome-associated tumors - Your performance status is good (ECOG 0-1) and you have a life expectancy of at least 12 weeks - You are willing to use contraception during the study **You may NOT be eligible if...** - You have recently received prior HIF inhibitors, chemotherapy, or major surgery (within 4 weeks) - Your blood oxygen is low or you require supplemental oxygen - You have had another cancer (not related to VHL syndrome) - You have a significant bleeding tendency, severe infection, or digestive disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral HS-10516

Oral HIF-2α inhibitor


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT06553339


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