Evaluating AV-380 for cancer patients with cachexia

A Phase 1B Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels

This study is testing a new treatment called AV-380 to see if it can help cancer patients who are struggling with weight loss and muscle wasting.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AVEO Pharmaceuticals, Inc. (Industry-sponsored)
• Locations: 12 sites (Beverly Hills, California and 11 other locations)
• Trial ID: NCT05865535 on ClinicalTrials.gov

What this trial studies

This open-label, ascending dose study aims to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of AV-380, a monoclonal antibody targeting GDF-15, in cancer patients suffering from cachexia. Participants will receive varying doses of AV-380 while actively undergoing standard of care therapy for their cancer. The study focuses on patients who meet specific criteria for cachexia, ensuring a targeted approach to treatment. The findings could provide insights into the effectiveness of AV-380 in managing this debilitating condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with solid tumor cancers who are experiencing cachexia and are receiving standard of care therapy.

Not a fit: Patients with a history of severe allergic reactions to monoclonal antibodies or those with untreated brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for cancer patients experiencing cachexia.

How similar studies have performed: While this approach is novel in targeting GDF-15 for cachexia, similar studies targeting cachexia in cancer patients have shown promise.

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.

Where this trial is running

Beverly Hills, California and 11 other locations

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

Study contacts

• Study coordinator: AVEO Clinical Trials Office

Conditions Cachexia