A Phase 1 interventional study of AV-380 in Cachexia, sponsored by AVEO Pharmaceuticals, Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by AVEO Pharmaceuticals, Inc. (part of LG Chem) · Phase 1, Interventional, and Treatment
This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's enrollment of 24 is below the median of 74 across 226 interventional studies indexed under Cachexia.
Browse Cachexia studies →AVEO Pharmaceuticals, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
First submitted after AVEO Pharmaceuticals, Inc. became part of LG Chem.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with cachexia as defined by Fearon criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental: Dose escalation cohorts of AV-380 administered by IV infusion
Biological: AV-380
AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
Assessment of adverse events (AEs)
AEs as characterized by incidence, type, frequency, and severity (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\])
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose
Toxicity
Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380
Time frame: While receiving study drug (up to 4 months)
Laboratory Abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (graded according to NCI-CTCAE v5.0) and timing.
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose.
Cmax
Maximum observed plasma concentration for AV-380
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
Tmax
Time to reach the Cmax for AV-380
Time frame: From first dose to the last follow-up visit approximately 60-days post dose
AUC(0-t)
Area under the plasma concentration-time curve from zero time to the last measurable point for AV-380
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
Immunogenicity
Serum levels of Anti-Drug Antibody (ADA) against AV-380 and their potential relationship with AEs and serum levels of GDF-15
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
Weight
Change from baseline body weight during the study
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose.
Patient-Reported Outcomes
Change from baseline in the following questionnaires: Functional Assessment of Anorexia Cachexia Therapy (FAACT); Patient global impression of severity (PGI-S) and patient global impression of change (PGI-C) for appetite, fatigue, and physical activity.
Time frame: From enrollment to the end of treatment, approximately 4 months
Lumbar (L3) Skeletal Muscle Index (L3SMI)
Measurement of a cross-sectional area of muscle at the level of the third lumbar vertebra (L3) using computed tomography (CT) scan
Time frame: From enrollment to the end of treatment, approximately 4 months
Physical Function
Change from baseline in physical function endpoints, including Short Physical Performance Battery test and digital measures of non-sedentary time
Time frame: From enrollment to the end of treatment, approximately 4 months
Serum level of GDF-15
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose.
Albumin and CRP
Change from baseline in albumin and CRP levels
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose.
Tumor status
Evaluate the effect of AV-380 on tumor burden and tumor status, per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose.
Biomarkers
including activin A and cytokine levels (e.g., monocyte chemoattractant protein-1 \[MCP-1\] and proinflammatory)
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rilogrotug