A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
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. 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) who have progressed on or after one prior line of systemic therapy. 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).
Arms & interventions
- Drugnuzefatide pevedotin (BT5528)
Participants will receive nuzefatide pevedotin (BT5528) via intravenous (IV) infusion every 2 weeks (Q2W)
Outcome measures
Primary
Objective Response Rate (ORR)
Percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator
Time frame: Up to approximately 3 years
Secondary
Duration of Response (DoR) per RECIST v1.1
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to approximately 3 years
Clinical Benefit Rate (CBR) per RECIST v1.1
Time frame: Up to approximately 3 years
Progression-Free Survival (PFS) per RECIST v1.1
Time frame: Up to approximately 3 years
Time to Progression (TTP) per RECIST v1.1
Time frame: Up to approximately 3 years
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 3 years
Incidence of treatment emergent serious adverse events (TESAEs)
Time frame: Up to approximately 3 years
Incidence of laboratory abnormalities
Time frame: Up to approximately 3 years
Incidence of ECG abnormalities
Time frame: Up to approximately 3 years
Incidence of abnormal vital signs
Time frame: Up to approximately 3 years
Incidence of treatment modification due to adverse events
Time frame: Up to approximately 3 years
Eligibility criteria
Study locations (2)
Siteman Cancer Center (Washington University School of Medicine)
St Louis, Missouri, 63108
Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office
Philadelphia, Pennsylvania, 19107