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RecruitingInterventionalPhase 1

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

NCT ID: NCT05865535Sponsor: AVEO Pharmaceuticals, Inc.Last updated: 2026-01-08

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. 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.

Arms & interventions

  • BiologicalAV-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.

Outcome measures

Primary

  • 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.

Secondary

  • 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.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (12)

Beverly Hills Cancer Center

Beverly Hills, California, 90211

Recruiting

Cancer and Blood Specialty Clinic

Lakewood, California, 90712

Recruiting

Hoag Memorial Hospital

Newport Beach, California, 92663

Recruiting

Hartford Hospital

Hartford, Connecticut, 06102

Recruiting

Advent Health Orlando Hospital

Orlando, Florida, 32804

Recruiting

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

Recruiting

Astera Cancer Care

East Brunswick, New Jersey, 08816

Recruiting

New York Cancer And Blood Specialists

Shirley, New York, 11967

Recruiting

Oregon Health and Science University

Portland, Oregon, 97239

Recruiting

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425

Recruiting

Vanderbilt University Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232

Recruiting

Community Clinical Trials

Kingwood, Texas, 77339

Recruiting
A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia | Cancerify