HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE for Colorectal cancer|Cancer cachexia

Inclusion criteria

• {"criterion_text":"- 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.\n- 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).\n- 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.\n- 5. Weigh at least 40 kg at enrollment (Study Day 1).\n- 6. Have ECOG PS 0-3.\n- 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.\n- 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."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Have life expectancy <6 months.\n- 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).\n- Receiving tube feedings or parenteral nutrition (either total or partial) at the time of Screening or Randomization.\n- 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).\n- Are planning to, or has undergone, major surgery within 28 days before Day 1.\n- Are pregnant or breastfeeding.\n- 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.\n- 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.\n- 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.\n- 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)."}

Primary endpoints

• {"endpoint_text":"- Change from baseline in body weight at Week 12","definition_or_measurement_approach":"Change from baseline body weight measured at baseline and at Week 12 (body weight difference from baseline to Week 12)."}
• {"endpoint_text":"- Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug","definition_or_measurement_approach":"Collection and characterization of TEAEs by type, frequency, severity, timing, seriousness and relationship to study drug using standard safety reporting procedures."}

Secondary endpoints

• {"endpoint_text":"- Key: Change from baseline in body weight at Week 16","definition_or_measurement_approach":"Change from baseline body weight measured at baseline and at Week 16."}
• {"endpoint_text":"- Change from baseline over time in: − FAACT sub-scale scores (FAACT-ACS, FAACT-5IASS) − PROMIS (fatigue 7a & physical function 8c) − PGI-S and PGI-C (appetite and fatigue) − PGI-S and PGI-C (physical activity and walking)","definition_or_measurement_approach":"Patient-reported outcome measures (FAACT sub-scales, PROMIS instruments, PGI-S and PGI-C) assessed over time versus baseline."}
• {"endpoint_text":"- Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug","definition_or_measurement_approach":"As per primary TEAE collection and characterization procedures."}
• {"endpoint_text":"- Change in body weight over time","definition_or_measurement_approach":"Serial body weight measurements over scheduled visits compared with baseline."}
• {"endpoint_text":"- Serum concentration and PK parameters of NGM120.","definition_or_measurement_approach":"Pharmacokinetic sampling to determine serum concentration and derived PK parameters of NGM120."}
• {"endpoint_text":"- Incidence and titer of ADA and NAb over time.","definition_or_measurement_approach":"Immunogenicity testing for anti-drug antibodies (ADA) and neutralizing antibodies (NAb) with incidence and titer measured over time."}

Slovakia

Earliest CTIS Part Ii Submission Date

08-10-2025

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

138

Number Of Sites

4

Number Of Participants

9

Poland

Earliest CTIS Part Ii Submission Date

08-10-2025

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

139

Number Of Sites

9

Number Of Participants

16

Czechia

Earliest CTIS Part Ii Submission Date

07-10-2025

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

140

Number Of Sites

4

Number Of Participants

9

Bulgaria

Earliest CTIS Part Ii Submission Date

09-10-2025

Latest Decision Or Authorization Date

25-02-2026

Processing Time Days

139

Number Of Sites

7

Number Of Participants

11

Hungary

Earliest CTIS Part Ii Submission Date

08-10-2025

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

139

Number Of Sites

3

Number Of Participants

9

Primary sponsor

Full Name

Ngm Biopharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

PK, ADA; PK and immunogenicity support

Name

Almac Clinical Services Limited

Responsibilities

QP release; clinical services

Name

Cti Clinical Trial Services Inc.

Responsibilities

Safety tests

Name

CTI Laboratory Services Spain S.L.

Responsibilities

Safety tests

Name

Frontage Laboratories Inc.

Responsibilities

Biomarker Services

Name

SanaClis s.r.o.

Responsibilities

Multiple clinical supply/operational codes (1,11,12,13,2,5,8)

Third parties

• {"country":"Spain","full_name":"CTI Laboratory Services Spain S.L.","duties_or_roles":"Safety tests","organisation_type":"Pharmaceutical company"}
• {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"Codes: 1,11,12,13,2,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"Biomarker Services; code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Actigraph LLC","duties_or_roles":"Wearable device","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cti Clinical Trial Services Inc.","duties_or_roles":"Safety tests","organisation_type":"Pharmaceutical company"}
• {"country":"Lithuania","full_name":"Biotechnologines farmacijos centras Biotechpharma UAB","duties_or_roles":"Codes: 14; 15 (QP release)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Biospecimen Management; code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"PK, ADA; code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Confirmatory reflex serology testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Codes: 14; 15 (QP release)","organisation_type":"Pharmaceutical company"}