Actively Recruiting
A Phase 1B Dose Escalation Study of AV-380 with Standard Chemotherapy in Metastatic Cancer Patients with Cachexia and Elevated GDF-15
Led by AVEO Pharmaceuticals, Inc. · Updated on 2026-01-08
30
Participants Needed
12
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AV-380, an immunoglobulin G1 monoclonal antibody designed to bind human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia. This phase 1B open-label dose escalation study aims to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of AV-380 in cancer patients who have cachexia and elevated GDF-15 levels. Participants have metastatic solid tumors and are actively receiving standard of care chemotherapy. Participants receive AV-380 through intravenous infusion in ascending dose cohorts alongside their standard chemotherapy treatments. The study includes a dose escalation phase where the safety and appropriate dosage of AV-380 are evaluated. This phase allows researchers to monitor the effects of increasing doses of AV-380 over a study period of up to 4 months while patients continue their usual cancer therapies. During the study, participants will undergo assessments including monitoring for adverse events, toxicity, and laboratory abnormalities from enrollment until about 60 days after the last dose. Pharmacokinetic measures such as maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the curve (AUC) will also be evaluated. The total involvement includes regular evaluations to track safety, drug behavior in the body, and immune responses to AV-380.
CONDITIONS
Brief 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 informed consent
- Histologically confirmed solid tumor cancer and currently receiving standard of care therapy
- Cachexia as defined by Fearon criteria: weight loss over 5% in past 6 months, or BMI under 20 with weight loss over 2%, or sarcopenia with weight loss over 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 severe heart failure within 3 months prior to study
- Uncontrolled pericardial effusion or frequent ascites drainage needed
- Cachexia caused by other conditions or uncontrolled reversible causes impairing oral intake
- Receiving tube feedings or parenteral nutrition at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 months
Participants receive escalating doses of AV-380 by intravenous infusion alongside standard chemotherapy for metastatic cancer with cachexia.
Duration - Approximately 60 days post dose
Participants are monitored for adverse events and laboratory abnormalities after completing treatment.
Approximately 1 to 2 visits
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
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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