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NCT05865535PHASE1Recruiting

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

AVEO Pharmaceuticals, Inc.

Start Date

6/13/2023

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

AV-380

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Conditions

Cachexia

Locations

Beverly Hills Cancer Center

Beverly Hills, California 90211

United States

Cancer and Blood Specialty Clinic

Lakewood, California 90712

United States

Hoag Memorial Hospital

Newport Beach, California 92663

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

Advent Health Orlando Hospital

Orlando, Florida 32804

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

New York Cancer And Blood Specialists

Shirley, New York 11967

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

MUSC Hollings Cancer Center

Charleston, South Carolina 29425

United States

Vanderbilt University Henry-Joyce Cancer Clinic

Nashville, Tennessee 37232

United States

Community Clinical Trials

Kingwood, Texas 77339

United States