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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Beverly Hills Cancer Center
Beverly Hills, California, United States
RECRUITINGCancer and Blood Specialty Clinic
Lakewood, California, United States
Assessment of adverse events (AEs)
AEs as characterized by incidence, type, frequency, and severity (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\])
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose
Toxicity
Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380
Time frame: While receiving study drug (up to 4 months)
Laboratory Abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (graded according to NCI-CTCAE v5.0) and timing.
Time frame: From enrollment to the last follow-up visit approximately 60-days post dose.
Cmax
Maximum observed plasma concentration for AV-380
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
Tmax
Time to reach the Cmax for AV-380
Time frame: From first dose to the last follow-up visit approximately 60-days post dose
AUC(0-t)
Area under the plasma concentration-time curve from zero time to the last measurable point for AV-380
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
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Hoag Memorial Hospital
Newport Beach, California, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITINGAdvent Health Orlando Hospital
Orlando, Florida, United States
RECRUITINGNebraska Cancer Specialists
Omaha, Nebraska, United States
RECRUITINGAstera Cancer Care
East Brunswick, New Jersey, United States
RECRUITINGNew York Cancer And Blood Specialists
Shirley, New York, United States
RECRUITINGOregon Health and Science University
Portland, Oregon, United States
RECRUITINGMUSC Hollings Cancer Center
Charleston, South Carolina, United States
RECRUITING...and 2 more locations