Study of NGM120 in patients with colorectal cancer and cancer cachexia: Evaluating effects on body weight

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What is this study about?

This study focuses on patients with colorectal cancer who have developed a condition called cancer cachexia, which is characterized by significant unintentional weight loss and muscle wasting. The study will test a new medication called NGM120, which is a type of humanized monoclonal antibody (a laboratory-created protein that targets specific cells in the body), comparing it with a placebo. The main purpose is to determine if NGM120 can help manage body weight in people with cancer cachexia.

The treatment will be given as an subcutaneous injection (an injection under the skin). The medication or placebo will be administered over several weeks, with participants being monitored for a total of 16 weeks. The maximum daily dose of NGM120 will be 200 milligrams, with a total maximum dose of 2000 milligrams over the course of treatment.

Throughout the study, participants will be evaluated for changes in their body weight and overall health status. The study will also look at how well the body tolerates NGM120 and track any side effects that may occur. Various aspects of participants’ well-being will be monitored, including their fatigue levels, physical function, appetite, and ability to perform daily activities.

1 Initial screening and enrollment

You will be evaluated to confirm the diagnosis of colorectal cancer and cancer cachexia (a condition involving weight loss and muscle loss).

Your weight and body measurements will be taken to verify eligibility criteria.

Your current weight must be at least 40 kg, and you must have experienced specific weight loss patterns in the past 6 months.

Your physical performance status will be evaluated using the ECOG scale (a measure of daily living abilities).

2 Treatment assignment

You will be randomly assigned to receive either NGM120 or placebo (an inactive substance).

Neither you nor your doctor will know which treatment you are receiving during the study.

3 Treatment administration

You will receive subcutaneous injections (injections under the skin) of either NGM120 or placebo.

Treatment will continue while maintaining your standard cancer care treatment.

4 Monitoring and assessments

Your weight will be measured regularly, with key assessments at week 12 and week 16.

You will complete questionnaires about your appetite, fatigue, physical activity, and walking ability.

Blood samples will be taken to measure drug levels and check for antibodies.

Any side effects or health changes will be monitored and recorded throughout the study.

5 Study completion

The study will evaluate how the treatment affects your body weight compared to the starting point.

Your overall health, side effects, and response to treatment will be assessed.

The study is expected to continue until December 2027.

Who Can Join the Study?

Must be 18 years or older and able to understand and sign an informed consent form
Must have a confirmed diagnosis of colorectal cancer (cancer that starts in the colon or rectum) and be receiving standard treatment
Must have cachexia (a condition causing severe weight loss and muscle wasting) with at least one of these:
- Body Mass Index less than 20 with unintentional weight loss greater than 2% in the past 6 months
- Current unintentional weight loss greater than 5% that hasn’t improved in the past 6 months
- Low muscle mass in arms and legs with unintentional weight loss greater than 2% in the past 6 months
Must weigh at least 40 kilograms when starting the study
Must have an ECOG Performance Status of 0-3 (a measure of daily living abilities, where 0 means fully active and 3 means capable of limited self-care and confined to bed or chair more than 50% of waking hours)
Must have either tried all available treatments for improving appetite and weight, have medical reasons preventing use of such treatments, or have no access to such treatments according to local medical standards

Who Cannot Join the Study?

History of other types of cancer in the past 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Active or untreated brain metastases (cancer that has spread to the brain)
Severe heart conditions, including:
- Heart attack within the last 6 months
- Unstable angina (chest pain)
- Heart failure requiring hospitalization within the last 6 months
Severe liver problems or abnormal liver function tests
Severe kidney disease requiring dialysis
Active, uncontrolled infections
Known HIV, active hepatitis B, or active hepatitis C infection
Major surgery within 4 weeks before starting the study
Participation in other clinical trials within 30 days before this study
Any condition that, in the opinion of the study doctor, would make it unsafe to participate
Pregnancy or breastfeeding
Unwillingness to use effective birth control methods during the study period

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Orszagos Onkologiai Intezet	Budapest	Hungary
MBAL Sveta Marina EAD	Varna	Bulgaria
Complex Oncological Center Plovdiv EOOD	Plovdiv	Bulgaria
MBAL Trakia EOOD	Stara Zagora	Bulgaria
MBAL Serdika Ltd.	Sofia	Bulgaria
Nemocnica Na Okraji Mesta N.O.	Partizanske	Slovakia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Semmelweis University	Budapest	Hungary
Narodny Onkologicky Ustav	Bratislava	Slovakia
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Pratia S.A.	Skorzewo	Poland
Multiprofile Hospital For Active Treatment Dobrich AD	Dobrich	Bulgaria
Pqno Pblijd smnglv	Poprad	Slovakia
Mlomeemdq slusqr	Horovice	Czechia
Rru Msxipo snguxq	Novy Knin	Czechia
Mhqrubo Cpzxqn Hmrzfy Rujm Lucc	Ruse	Bulgaria
Nmj Sjk Jqtsqf Binukzgy nxhj	Bardejov	Slovakia
Fucytlra nbuskxkdd Mjlot a Hpnppmt	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	30.09.2025
Czechia	Not yet recruiting	30.09.2025
Hungary	Recruiting	30.09.2025
Poland	Recruiting	30.09.2025
Slovakia	Recruiting	30.09.2025

Trial locations

Investigated drugs:

HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE

NGM120 is an investigational medication being studied for treating cancer cachexia (severe weight loss and muscle wasting) in patients with colorectal cancer. It is a novel therapeutic agent that aims to help patients maintain or regain body weight during their cancer treatment. The medication is being tested to understand how well it works in managing cachexia symptoms and to confirm if it is safe and well-tolerated by patients.

Investigated diseases:

Colorectal Cancer with Cancer Cachexia – A condition where colorectal cancer is accompanied by cancer cachexia, which is characterized by significant loss of body weight, muscle mass, and fat tissue. Colorectal cancer begins in the large intestine (colon) or rectum, while cachexia is a complex metabolic syndrome that develops as a secondary condition. Cancer cachexia causes ongoing weight loss that cannot be fully reversed by conventional nutritional support. This combined condition typically involves decreased appetite, reduced food intake, and significant changes in metabolism. The body’s response to the cancer leads to the breakdown of muscles and fat stores, resulting in progressive physical decline and weakness.

Trial ID:

2025-521730-28-00

Protocol code:

120-CX-202

NCT ID:

NCT07033026

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of NGM120 in patients with colorectal cancer and cancer cachexia: Evaluating effects on body weight

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?