136 Participants Needed

NGM120 for Colorectal Cancer and Wasting Syndrome

NS
Overseen ByNGM Study Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: NGM Biopharmaceuticals, Inc
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the drug NGM120 to determine its effectiveness for people with colorectal cancer who also experience cancer cachexia, a condition causing severe weight loss. The study assesses the effectiveness and safety of different NGM120 doses compared to a placebo. Participants will receive either a low or high dose of NGM120 or a placebo, administered every 4 or 8 weeks, assigned randomly. Ideal candidates for this trial have colorectal cancer and significant, unplanned weight loss due to cancer cachexia. As a Phase 2 trial, this research measures NGM120's effectiveness in an initial, smaller group, allowing participants to contribute to important treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NGM120 is likely to be safe for humans?

Research has shown that NGM120 is being tested for safety and effectiveness in people with colorectal cancer and cachexia, a condition characterized by severe weight loss and muscle wasting. In earlier studies, NGM120 was generally well-tolerated, with most patients not experiencing serious side effects. Common side effects included mild tiredness and nausea, which were manageable.

This study is in Phase 2, indicating that earlier trials have already demonstrated the treatment's safety. This phase focuses on confirming safety and assessing effectiveness. Overall, the data so far suggests that NGM120 is relatively safe for people, but more research is needed to fully understand its safety.12345

Why do researchers think this study treatment might be promising for colorectal cancer?

Researchers are excited about NGM120 because it offers a fresh approach to treating colorectal cancer and wasting syndrome. Unlike standard treatments like chemotherapy, which target rapidly dividing cells, NGM120 is designed to target specific pathways involved in cancer growth and metabolism. This potentially allows for more precise treatment with fewer side effects. Additionally, NGM120 is administered subcutaneously, which could be less invasive and more convenient compared to traditional intravenous chemotherapy. The possibility of using different dosing schedules, including high doses at extended intervals, offers flexibility that could enhance patient comfort and compliance.

What evidence suggests that NGM120 might be an effective treatment for colorectal cancer and wasting syndrome?

Research has shown that NGM120 might help treat colorectal cancer and cancer cachexia, a condition causing severe weight loss. In an earlier study, all six patients assessed after 16 weeks managed to keep their disease under control. Four of these patients gained more than 5% of their body weight, and on average, muscle weight increased by 2.9%. The treatment was well tolerated, with no major side effects preventing its use. In this trial, participants will be assigned to different treatment arms, including various dosages and schedules of NGM120 or placebo. These early results suggest that NGM120 could help patients gain weight and muscle, which is important for managing cachexia.23678

Who Is on the Research Team?

NS

NGM Study Director

Principal Investigator

NGM Biopharmaceuticals, Inc

Are You a Good Fit for This Trial?

This trial is for individuals with colorectal cancer experiencing cachexia, a condition causing weight loss and muscle wasting. Participants should not have had prior treatment with NGM120 or similar agents.

Inclusion Criteria

I have been diagnosed with active colorectal cancer.
Signed informed consent
Cachexia defined by Fearon criteria of weight loss

Exclusion Criteria

I am currently on tube feeding or IV nutrition.
Current active reversible causes of decreased food intake
Cachexia caused by other reasons

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NGM120 or placebo subcutaneously every 4 or 8 weeks

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

32 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NGM120
Trial Overview The study tests NGM120, given every 4 weeks (Q4W) or every 8 weeks (Q8W), against a placebo to see if it helps with cancer cachexia in colorectal cancer patients.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Placebo Group
Group I: NGM120 Treatment Group DExperimental Treatment1 Intervention
Group II: NGM120 Treatment Group CExperimental Treatment1 Intervention
Group III: NGM120 Treatment Group AExperimental Treatment1 Intervention
Group IV: NGM120 Treatment Group BPlacebo Group1 Intervention
Group V: NGM120 Treatment Group EPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NGM Biopharmaceuticals, Inc

Lead Sponsor

Trials
25
Recruited
2,500+

Citations

Study Details | NCT07033026 | An Evaluation of NGM120 ...A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.
Release DetailsThese results demonstrate that treatment with NGM120 was well tolerated to date in the study with no dose-limiting toxicities and provide encouraging signals ...
NGM120 for Colorectal Cancer and Wasting SyndromeA multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.
550P Initial results of a phase Ia/Ib study of NGM120, a ...Among the 6 evaluable pts, the disease control rate is 100% at wk 16 and 4 pts showed >5% BW gain and mean 2.9% LBM gain based on maximum change from baseline.
An Evaluation of NGM120 in a Randomized, Double-blind ...An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.
Current Therapeutic Targets in Cancer CachexiaThis article reviews two major thematic areas that are driving these pharmacologic strategies, including those targeting signal mediators at the level of the ...
Study of NGM120 in patients with colorectal cancer and ...NGM120 is an investigational medication being studied for treating cancer cachexia (severe weight loss and muscle wasting) in patients with colorectal cancer.
An Evaluation of NGM120 in a Randomized, Double-blind ...Evaluation of Efficacy, Safety and Tolerability of NGM120 in a Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study in ...
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