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

Recruiting now · Phase 1

Conditions studied: Cachexia

In brief

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.

Key facts

Study ID

NCT05865535

Run by

AVEO Pharmaceuticals, Inc.

People needed

30

Starts

2023-06-13

Expected to finish

2026-12-31

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Beverly Hills Cancer Center — Beverly Hills, California, United States (enrolling)
• Cancer and Blood Specialty Clinic — Lakewood, California, United States (enrolling)
• Hoag Memorial Hospital — Newport Beach, California, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Advent Health Orlando Hospital — Orlando, Florida, United States (enrolling)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• Astera Cancer Care — East Brunswick, New Jersey, United States (enrolling)
• New York Cancer And Blood Specialists — Shirley, New York, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• MUSC Hollings Cancer Center — Charleston, South Carolina, United States (enrolling)
• Vanderbilt University Henry-Joyce Cancer Clinic — Nashville, Tennessee, United States (enrolling)
• Community Clinical Trials — Kingwood, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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