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

Prior treatment

• Chemotherapy or radiotherapy within 14 days prior to the first dose of 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

Other

• Experimental treatments within 28 days or 5 half-lives, whichever is longer, of first dose of nuzefatide study treatment
• Untreated central nervous system (CNS) metastases
  • Note: Additional protocol defined Inclusion/Exclusion criteria apply

• 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.