What Is NGM120?
NGM120 is an investigational drug currently being studied in clinical trials. It is administered as a subcutaneous injection, meaning it is given under the skin. The specific way NGM120 works in the body is not detailed in the available trial descriptions. However, it is being investigated for its potential to treat various types of cancer and related conditions.
This drug is sponsored by NGM Biopharmaceuticals, Inc., an industry sponsor. Research into NGM120 has involved a total of three clinical trials, enrolling 317 participants. The first trial for NGM120 began on January 5, 2018, and the latest trial is expected to conclude by June 24, 2025. These studies aim to understand how NGM120 affects different conditions and to determine its safety and effectiveness.
Uses and Conditions Under Study
NGM120 is being investigated for its potential to treat a range of serious conditions, primarily focusing on various cancers and cancer-related complications. Clinical trials are exploring its effects across different disease areas.
A significant focus of the research is on several types of cancer. These include Colorectal Cancer, which has been studied in two trials (also referred to as CRC in one trial). Other cancers under investigation in one trial each include Esophageal Cancer, Gastric Cancer, Head Neck Squamous Cell Carcinoma, Melanoma, Metastatic Castration-resistant Prostate Cancer, and Non-small Cell Lung Cancer. For these cancers, NGM120 is being studied to see if it can help manage the disease or improve patient outcomes, potentially by targeting pathways involved in cancer growth or progression.
Another key area of study for NGM120 is cachexia, a complex metabolic wasting syndrome often associated with chronic diseases like cancer. Both general Cachexia and Cancer Cachexia are being investigated in one trial. This condition leads to significant weight loss, muscle wasting, and fatigue, which can severely impact a patient's quality of life and response to cancer treatments. NGM120 is being explored for its potential to address the underlying mechanisms contributing to this debilitating syndrome, aiming to improve nutritional status and overall well-being for patients.
Dosing
NGM120 is administered as a subcutaneous injection. This means the medication is injected under the skin, rather than into a vein or muscle. The specific dosage forms studied in clinical trials include different treatment groups and parts of studies, indicating varying regimens and strengths.
In clinical trials, NGM120 has been studied at different strengths and frequencies. These include doses of 30mg and 100mg. Some trial protocols specify administration every 4 weeks, while others mention every 3 weeks (Q3W). Specific dosage forms and regimens studied include:
- NGM120 Treatment Group A
- NGM120 Treatment Group C
- NGM120 Treatment Group D
- Part 1 NGM120 30mg
- Part 1 NGM120 100mg
- Part 2 NGM120 30mg
- Part 2 NGM120 100mg
- Part 3 NGM120 100mg Q3W
- Part A: NGM120
- Part B: NGM120
These varied approaches allow researchers to determine the most effective and safest dose for the conditions being investigated. The trials do not specify different dosing for pediatric patients; all mentioned dosages appear to be for adult study participants.
Side Effects
In clinical trials, the most common side effect reported for NGM120 was fatigue, experienced by 52.2% of patients taking NGM120, compared to 55.0% of patients receiving a placebo. Many side effects occurred at similar rates in both the NGM120 and placebo groups. However, some side effects were more frequent with NGM120, or occurred exclusively in patients taking the drug.
- Anemia (low red blood cell count) was reported in 41.8% of patients on NGM120, compared to 55.0% on placebo.
- Diarrhea affected 38.8% of patients taking NGM120, while 40.0% of patients on placebo experienced it.
- Peripheral edema (swelling in the limbs) occurred in 38.8% of patients on NGM120, compared to 35.0% on placebo.
- Nausea was reported by 35.8% of patients taking NGM120, versus 40.0% on placebo.
- Pyrexia (fever) was observed in 34.3% of patients on NGM120, significantly higher than the 20.0% of patients on placebo.
- Decreased neutrophil count (a type of white blood cell) was seen in 28.4% of patients on NGM120, compared to 45.0% on placebo.
- Weight decreased in 26.9% of patients taking NGM120, versus 30.0% on placebo.
- Cough was reported by 25.4% of patients taking NGM120, while no patients (0.0%) on placebo experienced this side effect.
Clinical Trial Results
NGM120 in Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer (NCT04068896)
A clinical trial (NCT04068896) investigated NGM120 in patients with advanced solid tumors, pancreatic cancer, and prostate cancer. The primary objective of this study was to determine the safety and tolerability of NGM120. A total of 64 participants were enrolled across different treatment groups and study parts for this assessment.
- For the 100 mg dose of NGM120, a total of 38 participants were included in the safety and tolerability evaluations across various parts of the study.
- For the 30 mg dose of NGM120, a total of 11 participants were included in the safety and tolerability evaluations.
- The placebo group included 15 participants for comparison in the safety and tolerability assessments.
This trial focused on understanding how well patients tolerated NGM120 and its safety profile across different dose levels. Specific efficacy outcomes, such as tumor response rates or disease progression, were not detailed in the provided data for this study.
Currently Recruiting Trials
Clinical trials are a vital step in evaluating new treatments and understanding their potential benefits for patients. NGM120 is currently being investigated in a study for patients living with colorectal cancer who are also experiencing a challenging condition called cancer cachexia.
The study, identified as NCT07033026, is a Phase 2, multi-center, randomized, double-blind, placebo-controlled evaluation of NGM120. This trial focuses on participants with colorectal cancer (CRC) who have cancer cachexia, a complex condition characterized by significant weight loss and muscle wasting. Researchers aim to understand how different dosages of NGM120, specifically Treatment Group A, Treatment Group C, and Treatment Group D, compare to a placebo in managing these conditions. The study is sponsored by NGM Biopharmaceuticals, Inc and plans to enroll approximately 136 participants. To be eligible, individuals must be 18 years old. The trial is open to all genders, but healthy volunteers and children are not able to participate, as the study specifically targets patients with the defined cancer conditions.
Where to Participate
Opportunities to participate in NGM120 studies are available across several regions. The current recruiting trial is being conducted at 1 site across 12 cities in 8 states, making it accessible to a broad range of potential participants.
Top locations for this study include:
- Los Angeles, California
- Santa Rosa, California
- Margate, Florida
- Baltimore, Maryland
- New York, New York
- Toledo, Ohio
- Youngstown, Ohio
- Dallas, Texas
- Kingwood, Texas
- Laredo, Texas
Participants must be 18 years old and of any gender. This study is specifically designed for patients with colorectal cancer and cancer cachexia, so healthy volunteers are not eligible to join.
Development Timeline
The journey of NGM120 began with its first clinical trial on January 5, 2018, initiated by NGM Biopharmaceuticals, Inc. This marked the start of evaluating the drug's potential. Initially, NGM120 was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia.
Over time, the development pipeline for NGM120 significantly expanded. The program has progressed through various phases, including one Phase 1 study, one Phase 1/Phase 2 study, and one Phase 2 study, demonstrating a systematic approach to understanding its effects. In total, three trials have been conducted or are ongoing, aiming to enroll a combined total of 317 participants.
The scope of conditions under investigation broadened considerably to include a wide range of cancers. This expansion reflects an evolving understanding of NGM120's potential applications, now encompassing conditions like Cancer Cachexia, Colorectal Cancer (CRC), Esophageal Cancer, Gastric Cancer, Head Neck Squamous Cell Carcinoma, Melanoma, Metastatic Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Bladder Cancer, and Prostate Cancer. The latest trial is projected to conclude by June 24, 2025, continuing the evaluation of NGM120's therapeutic promise.