BridgeMD
A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.
EU CTIS ID: 2025-521730-28-00
What this study is testing
To evaluate the effect of NGM120 compared to placebo on body weight (Part A) To evaluate safety and tolerability of NGM120 (Part B)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Must be at least 18 years of age, who comprehend and are willing to sign an Informed Consent Form (ICF), at the time of the Screening visit.
- 2. Documented histologic or cytologic diagnosis of CRC receiving standard of care treatment according to local/country specific practice guidelines (which may include systemic therapy).
- 3. Cachexia defined by Fearon criteria as at least one of the following: • Body mass index (BMI) <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to enrollment; or Current involuntary weight loss of >5% which has not improved over the past 6 months prior to enrollment, irrespective of BMI; or Sarcopenia as defined by appendicular skeletal muscle index (males <7.26 kg/m2 or females <5.45 kg/m2) with involuntary weight loss of >2% within 6 months prior to enrollment, irrespective of BMI.
- 5. Weigh at least 40 kg at enrollment (Study Day 1).
- 6. Have ECOG PS 0-3.
- 7. Male participants who are sexually active with a female partner of childbearing potential and female participants of childbearing potential must agree to use adequate birth control in consultation with Investigator from Screening to 4 months after the last dose of study drug. Refer to Section 6.9 on contraception methods.
You likely can't join if
- Have current active reversible causes of decreased food intake, as determined by the Investigator. These causes may include, but are not limited to the following: • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 oral mucositis; • NCI CTCAE Grade 3 or 4 gastrointestinal (GI) disorders (nausea, vomiting, diarrhea, and constipation); • Mechanical obstructions making the participant unable to eat.
- Have life expectancy <6 months.
- Participated in another investigational drug study with NGM120 or any other experimental therapy targeting glial cell-derived neurotrophic factor family receptor α-like (GFRAL) or growth differentiation factor 15 (GDF15).
- Receiving tube feedings or parenteral nutrition (either total or partial) at the time of Screening or Randomization.
- Have cachexia caused by other reasons, as determined by the Investigator, including, but not limited to: • Severe chronic obstructive pulmonary disease (COPD) requiring use of home O2 • New York Heart Association (NYHA) Class III-IV heart failure; or • Acquired immunodeficiency syndrome (AIDS).
- Are planning to, or has undergone, major surgery within 28 days before Day 1.
See the full eligibility criteria
Who can join
- 1. Must be at least 18 years of age, who comprehend and are willing to sign an Informed Consent Form (ICF), at the time of the Screening visit.
- 2. Documented histologic or cytologic diagnosis of CRC receiving standard of care treatment according to local/country specific practice guidelines (which may include systemic therapy).
- 3. Cachexia defined by Fearon criteria as at least one of the following: • Body mass index (BMI) <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to enrollment; or Current involuntary weight loss of >5% which has not improved over the past 6 months prior to enrollment, irrespective of BMI; or Sarcopenia as defined by appendicular skeletal muscle index (males <7.26 kg/m2 or females <5.45 kg/m2) with involuntary weight loss of >2% within 6 months prior to enrollment, irrespective of BMI.
- 5. Weigh at least 40 kg at enrollment (Study Day 1).
- 6. Have ECOG PS 0-3.
- 7. Male participants who are sexually active with a female partner of childbearing potential and female participants of childbearing potential must agree to use adequate birth control in consultation with Investigator from Screening to 4 months after the last dose of study drug. Refer to Section 6.9 on contraception methods.
- 4. Participants will be included in the study if they have exhausted all treatment options intended to increase appetite or body weight, have clear contraindications to such treatments, or cannot be administered these treatments for any other reasons based on the local standard-of-care or treatment availability per the Investigator.
What rules you out
- Have current active reversible causes of decreased food intake, as determined by the Investigator. These causes may include, but are not limited to the following: • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 oral mucositis; • NCI CTCAE Grade 3 or 4 gastrointestinal (GI) disorders (nausea, vomiting, diarrhea, and constipation); • Mechanical obstructions making the participant unable to eat.
- Have life expectancy <6 months.
- Participated in another investigational drug study with NGM120 or any other experimental therapy targeting glial cell-derived neurotrophic factor family receptor α-like (GFRAL) or growth differentiation factor 15 (GDF15).
- Receiving tube feedings or parenteral nutrition (either total or partial) at the time of Screening or Randomization.
- Have cachexia caused by other reasons, as determined by the Investigator, including, but not limited to: • Severe chronic obstructive pulmonary disease (COPD) requiring use of home O2 • New York Heart Association (NYHA) Class III-IV heart failure; or • Acquired immunodeficiency syndrome (AIDS).
- Are planning to, or has undergone, major surgery within 28 days before Day 1.
- Are pregnant or breastfeeding.
- Have any other significant medical, psychiatric, substance abuse problem, or history of suicidal ideation that would preclude participation in the study per Investigator’s assessment.
- Have prior allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (immunoglobulin G [IgG] protein) or molecules made of components of a monoclonal antibody.
- Are being initiated on new treatment with systemic glucocorticoids within the 4 weeks prior to the first dose of NGM120; stable (ie, no significant change to dosage or frequency of administration in prior 4 weeks) steroid therapy (eg, dexamethasone) as part of pre-medication or daily oral prednisone is permissible.
- Have elevated liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] ≥3.0×ULN, or ≥5.0×ULN if there is liver involvement by the tumor).
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Taiwan
- United States
- Georgia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Taiwan; United States; Georgia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.