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

Launched by AVEO PHARMACEUTICALS, INC. · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called AV-380 for patients with metastatic cancer who are experiencing cachexia, a condition that causes significant weight loss and muscle wasting. The goal of the study is to determine how safe AV-380 is, how it works in the body, and its potential side effects. AV-380 is designed to target a specific protein in the body that may contribute to cachexia, with hopes that it can help improve the quality of life for patients suffering from this condition.

To participate in the trial, patients need to be at least 18 years old and have been diagnosed with specific types of metastatic cancer, like colorectal or pancreatic cancer. They should also be currently receiving chemotherapy and have experienced weight loss or other symptoms of cachexia. During the trial, participants will receive increasing doses of AV-380, and their health will be closely monitored. This is an important opportunity for patients looking for new treatment options, but they should be aware that certain health conditions might exclude them from participating. If you or a loved one are interested, discussing this trial with a healthcare provider could provide more personalized insights.

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Eligibility criteria

• 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.