Ongoing Clinical Trials for Cachexia
This article provides information about ongoing clinical trials investigating new treatments for cachexia, a condition characterized by severe weight loss and muscle wasting in cancer patients. Currently, there is 1 clinical trial actively recruiting patients across multiple European countries, testing a medication called ponsegromab that targets elevated levels of a protein associated with cancer-related weight loss.
Clinical trial locations
- Bulgaria
- Poland
- Slovakia
- Spain
Study of ponsegromab for patients with cancer cachexia and elevated GDF-15 levels
This trial is investigating ponsegromab, a new medication designed to help cancer patients who are experiencing significant weight loss and muscle wasting. The condition being studied is cancer cachexia, which is different from regular malnutrition because it cannot be fully reversed by conventional nutritional support alone. This complex metabolic condition causes severe and ongoing loss of body weight, muscle mass, and fat tissue, and it significantly affects a patient’s ability to perform daily activities.
Who can participate?
This study is open to adults aged 18 years or older who have been diagnosed with one of three specific types of cancer: non-small cell lung cancer, pancreatic cancer, or colorectal cancer. Participants must be currently receiving or have completed standard cancer treatment. To be eligible, patients must have experienced unintentional weight loss that meets specific criteria: either a Body Mass Index less than 20 with weight loss greater than 2% in the past 6 months, or weight loss greater than 5% in the past 6 months regardless of Body Mass Index.
An important requirement is that participants must have elevated blood levels of a protein called GDF-15, specifically at 1.5 ng/mL or higher. This protein is believed to play a role in the development of cancer-related weight loss. Participants should also have a life expectancy of at least 4 months and be able to perform most daily activities with some assistance, as measured by an ECOG Performance Status of 3 or better.
Who cannot participate?
The study excludes individuals over 85 years of age, as well as women who are pregnant or breastfeeding. People with severe kidney problems, severe liver problems, or uncontrolled high blood pressure cannot join the trial. Those who have had a heart attack within the past 6 months or who have undergone major surgery within the past 4 weeks are not eligible. Additionally, patients with active infections requiring treatment, those who have participated in other clinical trials within the past 30 days, or those with a life expectancy of less than 6 months cannot participate.
What does the trial involve?
The study aims to determine if ponsegromab can help patients maintain or regain body weight compared to a placebo. The medication is administered as a subcutaneous injection, meaning it is given under the skin. The initial treatment period lasts 12 weeks, during which participants are randomly assigned to receive either ponsegromab or an inactive placebo.
Throughout the study, researchers closely monitor several aspects of participants’ health. Body weight is measured regularly to track any changes. Physical activity is assessed using special digital sensors that measure movement and walking speed. Participants complete questionnaires about their appetite, feelings of nausea, energy levels, and fatigue. Safety monitoring includes regular laboratory tests, vital signs checks, and heart activity measurements.
After the initial 12-week period, participants may have the option to continue in an open-label treatment phase, where all participants receive the active medication. The study is expected to continue until March 2025.
Investigational medication
Ponsegromab is a novel investigational monoclonal antibody, a type of targeted biological therapy. It works by targeting and neutralizing Growth Differentiation Factor-15 (GDF-15), the protein that plays a significant role in weight loss and muscle wasting associated with cancer. By blocking this protein, the medication aims to help patients preserve or restore body weight and muscle mass.
Summary
Currently, there is one active clinical trial for cancer cachexia, recruiting patients across four European countries: Bulgaria, Poland, Slovakia, and Spain. This trial focuses specifically on patients with elevated GDF-15 levels who have non-small cell lung cancer, pancreatic cancer, or colorectal cancer. The investigational medication ponsegromab represents a new approach to treating cancer-related weight loss by targeting the biological mechanisms that contribute to muscle wasting and weight loss. The trial emphasizes comprehensive monitoring of both weight changes and physical function, using modern digital sensors alongside traditional clinical assessments.