A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• At least 18 years of age at the time of signature of the informed consent form (or at least 19 years where locally defined as minimum age of consent).
• Measurable disease as defined by RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Life expectancy of at least 12 weeks.
• Histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
• Participants must have failed whose disease has progressed on or after only 1 prior line of therapy or on or after second line therapy with a KRAS inhibitor, with evidence of radiographic progression. Neoadjuvant or adjuvant systemic therapy may count as the first line if the participant progressed less than 6 months from the end of systemic therapy. Prior treatment with KRAS inhibitors in the first-line setting is permitted if there was no intervening treatment prior to enrollment.
• Participants must have sufficient tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers.
• Adequate organ function (hematologic, renal, and hepatic).
• Negative pregnancy test for participants of childbearing potential (POCBP)
• Must be willing and able to comply with the protocol and study procedures and agree to participate in the study by providing written informed consent.

You cannot join if

• Chemotherapy or radiotherapy within 14 days prior to the first dose of study treatment
• Experimental treatments within 28 days or 5 half-lives, whichever is longer, of first dose of nuzefatide study treatment
• Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer or prior treatment with any MMAE-containing agent
• Known microsatellite instability-high (MSI-H) status and are eligible for immune checkpoint inhibitor therapy
• Prior toxicities must have resolved to Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0
• Untreated central nervous system (CNS) metastases
• Note: Additional protocol defined Inclusion/Exclusion criteria apply

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• nuzefatide pevedotin (BT5528) (Drug): Participants will receive nuzefatide pevedotin (BT5528) via intravenous (IV) infusion every 2 weeks (Q2W)

Na · Single Group · masking: None

Main goals

• Objective Response Rate (ORR) (Up to approximately 3 years)

Other goals

• Duration of Response (DoR) per RECIST v1.1
• Overall Survival (OS)
• Disease Control Rate (DCR) per RECIST v1.1
• Clinical Benefit Rate (CBR) per RECIST v1.1
• Progression-Free Survival (PFS) per RECIST v1.1
• Time to Progression (TTP) per RECIST v1.1
• Incidence of treatment-emergent adverse events (TEAEs)
• Incidence of treatment-related adverse events (TRAEs)
• Incidence of treatment emergent serious adverse events (TESAEs)
• Incidence of laboratory abnormalities
• Incidence of ECG abnormalities
• Incidence of abnormal vital signs
• Incidence of treatment modification due to adverse events

Planned enrollment: 39 (estimated).

• Mayo Clinic Arizona, Phoenix, Arizona
• Mayo Clinic Florida, Jacksonville, Florida
• Mayo Clinic Rochester, Rochester, Minnesota
• Siteman Cancer Center (Washington University School of Medicine), St Louis, Missouri
• Memorial Sloan Kettering Cancer Center - Main Campus, New York, New York
• Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office, Philadelphia, Pennsylvania

2 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07450859

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 17, 2026. Public record; not medical advice.