A Study of Visugromab Compared to Placebo in Patients with Cancer-Related Cachexia to Test How Well It Works and How Safe It Is

Treatment assignment

Upon joining the trial, you will be randomly assigned to one of the treatment groups. This process is called randomization and ensures fairness in distributing participants across groups.

You will receive either visugromab, which is the medication being tested, or a placebo, which is an inactive substance that looks identical to the actual medication but contains no active ingredient.

Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind design and helps ensure the results are accurate and unbiased.

Medication administration

The study medication will be administered through an intravenous infusion, which means it will be given directly into your vein through a needle.

If you are assigned to receive visugromab, it will be given as a concentrate for solution for infusion, which is a liquid form that is prepared and then slowly delivered into your bloodstream.

The treatment will involve various doses of the medication, depending on which group you are assigned to.

Treatment period

The main treatment observation period will last for 12 weeks.

During this time, you will attend regular visits where your condition will be monitored and the study medication will be administered according to the schedule.

Body weight monitoring

Your body weight will be measured at the beginning of the trial to establish a baseline.

Your weight will be monitored throughout the trial, with a key measurement taken at 12 weeks to assess any changes from the starting point.

This measurement is one of the main ways the trial will evaluate whether the treatment is working.

Appetite assessment

Your appetite will be assessed using a questionnaire called the FAACT, which stands for Functional Assessment of Anorexia/Cachexia Therapy.

Specifically, you will complete a 5-item anorexia subscale, which is a short section of questions focused on your appetite and eating.

This assessment will be done at the start of the trial and again at 12 weeks to measure any changes in your appetite.

Muscle mass evaluation

Your skeletal muscle mass will be measured using imaging scans. These may include a CT scan or MRI scan, which are types of imaging that create detailed pictures of the inside of your body.

The scan will focus on the L3 level, which refers to a specific location in your lower back where muscle measurements are taken.

This helps determine if the treatment is affecting your muscle mass.

Physical function testing

You will perform a 30-second chair stand test, which is a simple physical test to measure your functional ability.

During this test, you will be asked to stand up and sit down from a chair as many times as possible in 30 seconds.

Your non-sedentary physical activity will also be monitored, which refers to the amount of time you spend being active rather than sitting or lying down.

Quality of life questionnaires

You will be asked to complete several questionnaires throughout the trial to assess your quality of life and how you are feeling.

The PGI-S, or Patient Global Impression of Severity, asks you to rate how severe your condition feels to you.

The PGI-C, or Patient Global Impression of Change, asks you to rate whether your condition has improved, stayed the same, or worsened.

You will also complete the EORTC-QLQ-C15 PAL, which is a questionnaire designed for people receiving palliative care, focusing on quality of life.

Blood sample collection

Blood samples will be collected at specific times during the trial to measure the levels of the study medication in your bloodstream.

The measurements will include Cmax, which is the highest concentration of the medication in your blood, and Cmin, which is the lowest concentration.

These measurements help determine how the medication is processed by your body.

Tumor response evaluation

Your tumor will be evaluated during the trial to see if there are any changes in its size or status.

This is done through standard imaging procedures and medical assessments as part of monitoring your cancer.

Safety monitoring

Throughout the trial, you will be monitored for any adverse events, which are unwanted or harmful effects that may occur.

The medical team will track the type and severity of any adverse events, including those that may be related to the study medication.

If you experience any serious adverse events or side effects that are difficult to tolerate, the treatment may be stopped.

Long-term follow-up

After the main 12-week treatment period, you may be followed for a longer period to assess overall survival, which means monitoring your health status over time.

This extended observation helps determine the long-term effects of the treatment.