CachexiaPhase 1NCT05865535
A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia
A Phase 1 study testing AV-380 in people with Cachexia, run by AVEO Pharmaceuticals, Inc. at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia
- What is being tested?
- AV-380
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 12 sitesUnited States
- Study dates
- 13 Jun 2023to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be ≥ 18 years of age at the time of signing the informed consent.
- Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.
- Patients with cachexia as defined by Fearon criteria:
- Weight loss > 5% over past 6 months (in absence of simple starvation), or
- BMI < 20 kg/m2 and any degree of weight loss > 2%, or
- Sarcopenia and any degree of weight loss > 2%
- Patients with life expectancy ≥ 3 months
Who cannot join
- History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment.
- Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy
- Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or HIV/AIDS), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability to eat as determined by the Investigator.
- Patients receiving tube feedings or parenteral nutrition at the time of Screening.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Beverly Hills Cancer Center
Beverly Hills, California, 90211
- Recruiting
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
- Recruiting
Astera Cancer Care
East Brunswick, New Jersey, 08816
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
- Recruiting
Community Clinical Trials
Kingwood, Texas, 77339
- Recruiting
Cancer and Blood Specialty Clinic
Lakewood, California, 90712
- Recruiting
Vanderbilt University Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
- Recruiting
Hoag Memorial Hospital
Newport Beach, California, 92663
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
- Recruiting
Advent Health Orlando Hospital
Orlando, Florida, 32804
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
- Recruiting
New York Cancer And Blood Specialists
Shirley, New York, 11967
About this study
Official title: A Phase 1B Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels
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.
- Conditions
- Cachexia
- Being tested
- AV-380
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-380Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohorts | Experimental | Experimental: Dose escalation cohorts of AV-380 administered by IV infusion Receives: Biological: AV-380 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Measured: 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
Measured: 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.
Measured: From enrollment to the last follow-up visit approximately 60-days post dose.
Secondary outcomes (3)
Cmax
Maximum observed plasma concentration for AV-380
Measured: From first dose to the last follow-up visit approximately 60-days post dose.
Tmax
Time to reach the Cmax for AV-380
Measured: 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
Measured: From first dose to the last follow-up visit approximately 60-days post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start13 Jun 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865535
- Sponsor's protocol ID
- AV-380-22-102
- Status last verified
- Jan 2026
- First submitted
- 2 May 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels
- ClinicalTrials.gov ID
- NCT05865535
- Acronym / sponsor ID
- AV-380-22-102
- Conditions
- Cachexia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohorts | Experimental | Biological: AV-380Experimental: Dose escalation cohorts of AV-380 administered by IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must be ≥ 18 years of age at the time of signing the informed consent.
- Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.
- Patients with cachexia as defined by Fearon criteria:
- Patients with life expectancy ≥ 3 months
Key exclusion criteria (6 listed)
- History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment.
- Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy
- Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or HIV/AIDS), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability to eat as determined by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-380AV-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. | Biological | Dose Escalation Cohorts |
Primary outcome
Assessment of adverse events (AEs)
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose
AEs as characterized by incidence, type, frequency, and severity (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE])
Toxicity
Time frame: While receiving study drug (up to 4 months)
Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380
Laboratory Abnormalities
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose.
Laboratory abnormalities as characterized by type, frequency, severity (graded according to NCI-CTCAE v5.0) and timing.
3 secondary outcomes
Cmax
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
Tmax
Time frame: From first dose to the last follow-up visit approximately 60-days post dose
AUC(0-t)
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AV-380 in people with Cachexia, run by AVEO Pharmaceuticals, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AVEO Clinical Trials Office ((857)400-0101, clinical@aveooncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adverse events (AEs) (time frame: From enrollment to the last follow-up visit approximately 60-days post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.