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Study of ponsegromab for patients with cancer cachexia and elevated GDF-15 levels

Fast replyInvestigationalNo placebo

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What is this trial about?

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

This study focuses on cancer cachexia, a condition where cancer patients experience significant weight loss and muscle wasting. The research evaluates a new medication called ponsegromab, which is being tested in patients who have non-small cell lung cancer, pancreatic cancer, or colorectal cancer along with cachexia. These patients must also have elevated levels of a substance called GDF-15 in their blood.

The study aims to determine if ponsegromab can help patients maintain or regain body weight compared to placebo. The medication is given as a subcutaneous injection, which means it is administered under the skin. The treatment period lasts for 12 months, during which patients receive either ponsegromab or a placebo.

During the study, researchers will monitor changes in body weight and physical activity. They will also track how well patients can move around and perform daily activities. The study includes the use of special sensors that measure movement and walking speed. Patients will also be asked about their appetite, feelings of nausea, and energy levels. Throughout the study, doctors will closely monitor the safety of the treatment by checking for any side effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation and treatment start
Your eligibility for the study will be confirmed based on specific criteria, including having cancer (specifically NSCLC, pancreatic, or colorectal cancer), cachexia (significant unintentional weight loss), and elevated levels of a protein called GDF-15
You will be randomly assigned to receive either ponsegromab or a placebo (inactive substance) through subcutaneous injection (under the skin)
Your current weight will be measured to establish a baseline for comparing future changes
Step 2
Treatment period - Part A
The initial treatment period will last for 12 weeks
During this time, you will receive regular subcutaneous injections of either ponsegromab or placebo
Your weight will be monitored regularly to track any changes
Your physical activity will be measured using digital sensors to track various movements and activity levels
You will complete questionnaires about your appetite, nausea, fatigue, and other symptoms
Regular safety monitoring will include laboratory tests, vital signs checks, and heart activity (ECG) measurements
Step 3
Optional open-label treatment period
After the initial 12-week period, you may have the option to continue treatment in an open-label format
During this period, all participants will receive the active medication (ponsegromab)
Monitoring of your health status, weight, and safety parameters will continue
Step 4
Study completion
The study is expected to continue until March 2025
Final evaluations will include weight measurements, physical activity assessments, and safety monitoring
All study-related activities will be completed according to the research protocol

Who can join the trial?

15 criteria

Must be at least 18 years old and able to provide informed consent
Women must not be pregnant or breastfeeding
check
Must have a confirmed diagnosis of one of these cancers:
- Non-small cell lung cancer (NSCLC)
- Pancreatic cancer (PANC)
- Colorectal cancer (CRC)
- Must be currently receiving or have completed standard cancer treatment
- check
  Must have cachexia (loss of body mass) meeting one of these conditions:
  - Body Mass Index less than 20 with unintentional weight loss greater than 2% in the past 6 months
  - Unintentional weight loss greater than 5% in the past 6 months regardless of Body Mass Index
  - Must have blood levels of GDF-15 (a specific protein) of 1.5 ng/mL or higher
  - Must have an ECOG Performance Status (a measure of daily living abilities) of 3 or better
  - Must have a life expectancy of at least 4 months
  - Must be willing and able to:
    
    Attend all scheduled visits
    Follow the treatment plan
    Complete required laboratory tests
    Follow study requirements

Who cannot join the trial?

15 criteria

Age below 18 years or above 85 years
Pregnant or breastfeeding women
History of severe allergic reactions to similar medications
Active infections requiring treatment
Severe kidney problems (as measured by creatinine clearance below 30 mL/min)
Severe liver problems (indicated by liver enzyme levels more than 3 times the normal range)
Participation in other clinical trials within the past 30 days
Major surgery within the past 4 weeks
Uncontrolled high blood pressure (defined as systolic blood pressure above 160 mmHg or diastolic blood pressure above 100 mmHg)
Unstable heart conditions including heart attack within the past 6 months
Mental conditions that could interfere with following study procedures
Use of medications that could interact with the study drug
History of drug or alcohol abuse within the past year
Life expectancy less than 6 months
Unable to provide informed consent

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Fundacion Instituto Valenciano De Oncologia
Valencia, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Verified
Hospital Universitario Y Politecnico La Fe
Valencia, Spain

Trial locations

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Investigated drugs

Ponsegromab is an investigational medication designed to treat cancer cachexia, a condition that causes severe weight loss and muscle wasting in cancer patients. The medication targets elevated levels of GDF-15, a protein that may contribute to the development of cachexia. It works by attempting to help patients maintain or regain body weight when dealing with cancer-related weight loss.

Ponsegromab

What is already known about the treatment

Ponsegromab - A novel investigational monoclonal antibody administered through intravenous infusion, currently being studied in clinical trials for the treatment of cancer cachexia, particularly in patients with elevated GDF-15 levels. This medication works by targeting and neutralizing Growth Differentiation Factor-15 (GDF-15), a protein that plays a significant role in weight loss and muscle wasting associated with cancer cachexia. Ponsegromab belongs to the class of targeted biological therapies and represents a potential therapeutic approach for addressing the severe weight loss and muscle deterioration that commonly affects cancer patients.

Investigated diseases

Cancer cachexia – A complex metabolic condition characterized by severe and ongoing loss of body weight, muscle mass, and fat tissue that occurs in people with cancer. It develops progressively through various stages, starting with minor weight loss and advancing to severe muscle wasting. The condition typically involves decreased appetite, reduced food intake, and significant changes in metabolism. Cancer cachexia affects the patient's physical function and ability to perform daily activities. The condition is different from regular malnutrition as it cannot be fully reversed by conventional nutritional support alone.