Actively Recruiting
A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia
Led by AVEO Pharmaceuticals, Inc. · Updated on 2026-01-08
30
Participants Needed
12
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older at the time of signing the informed consent.
- Histologically confirmed solid tumor cancer with active standard of care therapy.
- Presence of cachexia defined by either weight loss > 5% over the past 6 months, or BMI < 20 kg/m2 with weight loss > 2%, or sarcopenia with weight loss > 2%.
- Life expectancy of 3 months or more.
You will not qualify if you...
- History of allergic or anaphylactic reaction to monoclonal antibodies or related molecules.
- Known brain metastases or cranial epidural disease unless treated and stable for at least 2 weeks before first dose.
- Recent myocardial infarction or heart failure (NYHA Grade 3-4) within 3 months before starting therapy.
- Uncontrolled pericardial effusion or ascites requiring frequent drainage.
- Cachexia due to other causes such as severe COPD, heart failure, or HIV/AIDS, or uncontrolled reversible causes of reduced oral food intake.
- Receiving tube feedings or parenteral nutrition at screening.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Cancer and Blood Specialty Clinic
Lakewood, California, United States, 90712
Actively Recruiting
3
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Actively Recruiting
4
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
5
Advent Health Orlando Hospital
Orlando, Florida, United States, 32804
Actively Recruiting
6
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
7
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
8
New York Cancer And Blood Specialists
Shirley, New York, United States, 11967
Actively Recruiting
9
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
10
MUSC Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
11
Vanderbilt University Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232
Actively Recruiting
12
Community Clinical Trials
Kingwood, Texas, United States, 77339
Actively Recruiting
Research Team
A
AVEO Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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