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

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 receivingSoC therapy for this cancer.

3. Patients with cachexia as defined by Fearon criteria:

4. Weight loss > 5% over past 6 months (in absence of simple starvation), or

5. BMI < 20 kg/m2 and any degree of weight loss > 2%, or

6. Sarcopenia and any degree of weight loss > 2%

7. Patients with life expectancy ≥ 3 months

Exclusion Criteria:

1. History of allergic or anaphylactic reaction to any monoclonal antibody (IgGprotein) or molecules made of components of monoclonal antibody

2. Known brain metastases or cranial epidural disease unless adequately treated withradiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeksbefore first dose of study treatment.

3. Myocardial infarction or heart failure of New York Heart Association Grade 3-4within 3 months prior to start of protocol therapy

4. Uncontrolled pericardial effusion, or ascites requiring recurrent drainageprocedures (once monthly or more frequently)

5. Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonarydisease, heart failure, or HIV/AIDS), or the patient has uncontrolled reversiblecauses of reduced oral food intake, including, but not limited to, oral mucositis,nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability toeat as determined by the Investigator.

6. Patients receiving tube feedings or parenteral nutrition at the time of Screening.