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Brief Title: A Dose Escalation Study of AV-380 in Metastatic Cancer Patients With Cachexia
Official Title: A Phase 1 Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels
Study ID: NCT05865535
Brief Summary: This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in metastatic 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Advent Health Orlando Hospital, Orlando, Florida, United States
Piedmont Cancer Institute, Atlanta, Georgia, United States
Piedmont Cancer Institute, Atlanta, Georgia, United States
Piedmont Cancer Institute, Fayetteville, Georgia, United States
Piedmont Cancer Institute, Newnan, Georgia, United States
Piedmont Cancer Institute, Stockbridge, Georgia, United States
New York Cancer And Blood Specialists, Babylon, New York, United States
North Shore Hematology Oncology Associates P.C. dba NY Cancer and Blood Specialists, Bronx, New York, United States
New York Cancer and Blood Specialists, New York, New York, United States
New York Cancer And Blood Specialists, Patchogue, New York, United States
New York Cancer and Blood Specialists, Port Jefferson Station, New York, United States
New York Cancer And Blood Specialists, Riverhead, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
MUSC Hollings Cancer Center, Charleston, South Carolina, United States
Medical Oncology Associates, Spokane Valley, Washington, United States
Medical Oncology Associates, Spokane, Washington, United States