Testing a new medication for kidney tumors linked to von Hippel-Lindau syndrome

Plain-English translation of NCT06553339 on ClinicalTrials.gov ↗ · Source last updated August 2024 · Translation generated August 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new medication called HS-10516 for people who have tumors related to von Hippel-Lindau (VHL) syndrome, a genetic condition that causes multiple tumors to grow in the body. The study will first find the right dose of the medication that is both safe and tolerable, then test whether it actually works to shrink or control these tumors.

People with VHL syndrome often develop serious kidney tumors and other cancers that are difficult to treat with existing therapies. This trial is exploring whether this medication offers a new treatment option for these patients.

Do you qualify?

You likely qualify if…

you are between 18 and 80 years old
you have been diagnosed with advanced kidney cancer or tumors related to von Hippel-Lindau syndrome
you are in good enough health to participate (Eastern Cooperative Oncology Group performance status of 0-1, meaning you can do most normal activities)
you have a life expectancy of at least 12 weeks
you are willing and able to use reliable birth control throughout the study and understand the informed consent process

You likely don't qualify if…

you have received certain cancer treatments within the past 2–4 weeks (such as chemotherapy, other investigational drugs, radiation, or surgery)
you have oxygen levels below 92% at screening or require supplemental oxygen
you have not fully recovered from severe side effects (grade 2 or higher) from previous cancer treatments
you have a history of a different type of cancer unrelated to VHL syndrome
you have serious bleeding problems or severe infections in the past month, or digestive disorders that could interfere with absorbing the medication

What participation looks like

You would take the medication by mouth once daily. The trial has two phases: first, researchers will gradually increase doses to find the safest and most tolerable dose, and then additional participants will be enrolled to confirm the dose works and monitor side effects. You will be evaluated based on the size of your tumors—some participants will have smaller tumors (3 cm or less), others will have larger ones, and some may have non-kidney tumors. Throughout the study, you will have regular check-ups, blood tests, and scans to monitor your health and how well the treatment is working.

AI-generated summary from trial data · Aug 5, 2026 · Not medical advice

Trial locations(1 site)

China

Peking University First Hospital, Beijing, Beijing Municipality