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New drug aims to reverse wasting in cancer patients

NCT ID NCT05865535

Symptom relief Sponsor: AVEO Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests AV-380, an antibody that blocks a protein linked to cancer-related weight loss (cachexia). About 30 adults with advanced solid tumors and high GDF-15 levels will receive AV-380 alongside their standard chemotherapy. The main goal is to check safety and find the right dose.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient must be ≥ 18 years of age at the time of signing the informed consent. 2. Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer. 3. Patients with cachexia as defined by Fearon criteria: 1. Weight loss \> 5% over past 6 months (in absence of simple starvation), or 2. BMI \< 20 kg/m2 and any degree of weight loss \> 2%, or 3. Sarcopenia and any degree of weight loss \> 2% 4. Patients with life expectancy ≥ 3 months Exclusion Criteria: 1. History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody 2. 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. 3. Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy 4. Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) 5. 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. 6. Patients receiving tube feedings or parenteral nutrition at the time of Screening.

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Conditions

The condition(s) this trial relates to.

Cachexia neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cachexia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advent Health Orlando Hospital

    RECRUITING

    Orlando, Florida, 32804, United States

  • Astera Cancer Care

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Beverly Hills Cancer Center

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Cancer and Blood Specialty Clinic

    RECRUITING

    Lakewood, California, 90712, United States

  • Community Clinical Trials

    RECRUITING

    Kingwood, Texas, 77339, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Hoag Memorial Hospital

    RECRUITING

    Newport Beach, California, 92663, United States

  • MUSC Hollings Cancer Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • New York Cancer And Blood Specialists

    RECRUITING

    Shirley, New York, 11967, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Vanderbilt University Henry-Joyce Cancer Clinic

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.