Not yet recruitingRare disease

Phase 2 Study Evaluating Safety and Efficacy of Belzutifan in Adults with Solid Tumors

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

A clinical investigation is focused on adults with neoplasm malignant, which are cancers that form solid tumors in various organs. The study medication is belzutifan, an oral tablet taken at a dose of 120 mg each day.

The purpose of the study is to evaluate the safety of belzutifan. Participants will receive the medication for several months and will attend regular visits where doctors will check for any side effects, perform simple blood tests, and may use imaging scans to look at the tumor. A “Phase 2” study means the drug has already been tested for basic safety and is now being examined more closely for how well it works and how safe it is in a larger group.

During the trial, any unwanted health problems, called adverse events, will be recorded, and if a serious problem occurs, the medication may be stopped. The overall aim is to gather information that helps determine whether belzutifan can be used safely in people with solid tumor cancers.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After you are accepted into the study, you sign a consent form that explains what will happen and you complete the required paperwork.
Step 2
Baseline assessments
The study team collects information about your medical history, performs a physical examination, and takes blood samples and imaging studies to document the condition of your tumor before treatment begins.
Step 3
Starting medication
You receive belzutifan tablets. each tablet contains 120 mg of the active substance and is taken by mouth. the tablet is film‑coated, which means it has a thin protective layer. you take one tablet each day as directed by the study doctor.
Step 4
Regular monitoring visits
You attend scheduled clinic visits, typically every four weeks, where the study staff checks your health, measures blood levels of the drug, and records any changes in your condition.
During each visit you may have blood tests, urine tests, and possibly imaging to see how the tumor responds.
Step 5
Reporting adverse events
If you experience any new symptoms, such as fatigue, nausea, or any other change in how you feel, you tell the study staff right away. these symptoms are called adverse events and are recorded to evaluate safety.
Step 6
Dose adjustments or discontinuation
Based on the safety information collected, the study doctor may decide to keep the dose the same, reduce it, or stop the medication altogether if the side effects are significant.
Step 7
Study completion and final assessment
When the planned treatment period ends or the study is closed, you undergo a final set of examinations to evaluate the overall outcome, including tumor response and any lasting side effects.

Who can join the trial?

4 criteria

Must have a diagnosis of one of the following tumor types: locally advanced (cancer that has grown but not spread far), unresectable (cannot be removed by surgery), or metastatic (has spread to other parts of the body) pheochromocytoma or paraganglioma (rare hormone‑producing tumors), or a wild‑type gastrointestinal stromal tumor (a stomach or intestinal tumor without certain genetic changes), or a localized tumor that is linked to von Hippel‑Lindau disease (a hereditary condition that can cause tumors).
Must have disease that can be measured using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST), which is a set of rules doctors use to track tumor size on scans.
Both men and women are eligible to participate.
Must be an adult (generally 18 years of age or older).

Who cannot join the trial?

9 criteria

Having a blood‑oxygen level below 92% while at rest, needing extra oxygen only sometimes, or needing continuous (chronic) oxygen support. (pulse oximeter = a device that measures how much oxygen is in your blood)
Having serious heart disease, an electrocardiogram (ECG) that shows an uncontrolled heart problem, or a birth‑related condition called long QT syndrome (a type of heart rhythm disorder). (electrocardiogram = a test that records the electrical activity of the heart)
Having ever been infected with the human immunodeficiency virus (HIV), which can affect the immune system.
Having taken any drug that blocks a protein called hypoxia‑inducible factor‑2α, including the study drug belzutifan, before.
Having received a tissue or solid organ transplant from another person (an allogenic transplant).
Having had a stem‑cell transplant using your own cells (autologous stem cell transplant) within the last 6 months before the study starts.
Having another cancer that is getting worse or that needed active treatment in the past 2 years.
Having cancer that has spread to the brain or spinal cord (active central nervous system metastases) or a condition called carcinomatous meningitis (cancer affecting the protective membranes around the brain and spinal cord).
Having an infection that currently requires medication taken by mouth or through the bloodstream (systemic therapy).

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Verified sites

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Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Verified
Milan, Italy
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

Belzutifan is an oral medication taken as a film‑coated tablet. It works by blocking a protein that helps cancer cells grow when oxygen levels are low. In this study the drug is being tested to see if it is safe and can help treat solid tumors. Participants will take the tablet while doctors monitor them for any side effects and how the tumor responds.

Belzutifan

What is already known about the treatment

Belzutifan - Belzutifan is taken by mouth as a film‑coated tablet, each dose containing 120 mg. It is an investigational drug that has received FDA approval for certain rare kidney cancers and is being studied in clinical trials for other solid tumors. The medicine works by blocking a protein called HIF‑2α, which helps stop abnormal blood vessel growth that tumors need to survive. It belongs to the class of HIF‑2α inhibitors, a type of targeted therapy used to treat cancer.

Investigated diseases

Malignant neoplasm - Malignant neoplasm is a disease in which abnormal cells grow without normal control. These cells form a mass that can invade surrounding tissues. Over time the tumor can spread to other parts of the body through the bloodstream or lymph system. The disease often begins with a small area of uncontrolled growth that gradually enlarges. As it expands, it may affect the function of the organ where it originated. The spread to distant sites marks a more advanced stage of the condition.