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

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What is this study about?

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.

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

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

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

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 Study?

Must be at least 18 years old and able to provide informed consent
Women must not be pregnant or breastfeeding
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
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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland

Other Sites

Site Name	City	Country
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
University Hospital Bratislava	Bratislava	Slovakia
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Fakultna Nemocnica Trnava	Trnava	Slovakia
Complex Oncology Center Ruse EOOD	Ruse	Bulgaria
Centrum Pulmonologii I Torakochirurgii W Bystrej	Wilkowice	Poland
Fakultna Nemocnica S Poliklinikou Nove Zamky	Nove Zamky	Slovakia
Nemocnica Na Okraji Mesta N.O.	Partizanske	Slovakia
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
National Specialised Hospital For Active Treatment Of Haematological Diseases	Sofia	Bulgaria
Multidisciplinary Hospital For Active Treatment Haskovo AD	Haskovo	Bulgaria
Complex Oncological Center – Shumen EOOD	Shumen	Bulgaria
Szpital Specjalistyczny W Prabutach Sp. z o.o.	Prabuty	Poland
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Complex Oncology Center Vratsa EOOD	Vratsa	Bulgaria
Rzgfttosby Sejwzgo Sdajiytxsxpkjuu Igr Dkb Wyfwmwlvec Blccocurvhzv	Grudziadz	Poland
Nwlt Ckxaqx fxs Eavcu Dsxotbwgm asg Trnewsutb ot Cppbkh	Katowice	Poland
Cldjqqi Ozzxsqbk Cuumnw Bzjkga Ecdw	Burgas	Bulgaria
Hnvhsnjn Vtvh dgtjosmj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	21.11.2022
Poland	Not recruiting	21.11.2022
Slovakia	Not recruiting	21.11.2022
Spain	Not recruiting	21.11.2022

Trial locations

Investigated drugs:

Ponsegromab

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.

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.

Trial ID:

2023-510446-24-00

Protocol code:

C3651003

NCT ID:

NCT05546476

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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