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Recruiting

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

NCT07450859 · BicycleTx Limited
In plain English

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Official title
A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
About this study
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).
Eligibility criteria
Inclusion Criteria * At least 18 years of age at the time of signature of the informed consent form * 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 only 1 prior line of therapy 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 is permitted * 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 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 design
Enrollment target: 39 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-05
Estimated completion: 2029-05
Last updated: 2026-04-22
Interventions
Drug: nuzefatide pevedotin (BT5528)
Primary outcomes
  • Objective Response Rate (ORR) (Up to approximately 3 years)
Sponsor
BicycleTx Limited · industry
Contacts & investigators
ContactBicycleTx Limited · contact · clinicalstudies@bicycletx.com · 617-945-8155
All locations (1)
Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials OfficeRecruiting
Philadelphia, Pennsylvania, United States
A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) · TrialPath