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A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Trial Status: active
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.
Inclusion Criteria
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.
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.
Exclusion Criteria
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07450859.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
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
