NGM120 for Colorectal Cancer and Wasting Syndrome
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive NGM120 or placebo subcutaneously every 4 or 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NGM120
Find a Clinic Near You
Who Is Running the Clinical Trial?
NGM Biopharmaceuticals, Inc
Lead Sponsor