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

Inclusion criteria

• 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

Exclusion criteria

• 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.