A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Start Date
3/5/2026
Completion Date
5/1/2029
Summary
This is a Phase 2 study for nuzefatide pevedotin (BT5528) in adults with a specific type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and worsened after one previous treatment or two prior lines of treatment if treated with KRAS inhibitor. The drug, nuzefatide pevedotin (nuzefatide), is designed to find a specific protein called EphA2. The main aims of the study are to see how well the drug works against the tumor (efficacy), what side effects it may have (safety), and how the body processes it (pharmacokinetics). All participants in this study will receive nuzefatide, and both they and their doctors will know what is being administered (single-arm, open-label). The trial will take place at several different medical centers.
Detailed Description
This is a Phase 2, open-label, multicenter, single-arm study to evaluate the efficacy, safety, and pharmacokinetics (PK) of nuzefatide in adult participants with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on or after one prior line of systemic therapy in the metastatic setting or on or after second line therapy with a KRAS inhibitor in the metastatic setting. Nuzefatide is a novel Bicycle® drug conjugate (BDC®) that targets EphA2, a protein often found on cancer cells, and delivers a potent anti-cancer agent (MMAE).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
nuzefatide pevedotin (BT5528)
Conditions
Locations
Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Siteman Cancer Center (Washington University School of Medicine)
St Louis, Missouri 63108
United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York 10065
United States
Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office
Philadelphia, Pennsylvania 19107
United States
Seoul National University Hospital
Seoul, 03080
South Korea
Samsung Medical Center
Seoul, 06351
South Korea