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
Summary
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.
Arms & interventions
- BiologicalAV-380
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.
Outcome measures
Primary
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.
Secondary
Cmax
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
Tmax
Time frame: From first dose to the last follow-up visit approximately 60-days post dose
AUC(0-t)
Time frame: From first dose to the last follow-up visit approximately 60-days post dose.
Eligibility criteria
Study locations (12)
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Cancer and Blood Specialty Clinic
Lakewood, California, 90712
Hoag Memorial Hospital
Newport Beach, California, 92663
Hartford Hospital
Hartford, Connecticut, 06102
Advent Health Orlando Hospital
Orlando, Florida, 32804
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Astera Cancer Care
East Brunswick, New Jersey, 08816
New York Cancer And Blood Specialists
Shirley, New York, 11967
Oregon Health and Science University
Portland, Oregon, 97239
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
Vanderbilt University Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Community Clinical Trials
Kingwood, Texas, 77339