Actively Recruiting
Phase 2 Study of Nuzefatide Pevedotin BT5528 Treatment in Adults With Metastatic Pancreatic Ductal Adenocarcinoma After One Prior Therapy
Led by BicycleTx Limited · Updated on 2026-06-30
39
Participants Needed
3
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating nuzefatide pevedotin BT5528, a novel drug designed to target the protein EphA2, in adults with metastatic pancreatic ductal adenocarcinoma PDAC that has worsened after one prior treatment. This Phase 2, open-label, multicenter study aims to assess how well the drug works against the tumor, its safety profile, and how the body processes it. Participants will receive nuzefatide pevedotin through an intravenous infusion every two weeks. All participants will be given the study drug, and neither placebo nor alternative treatments are involved. The study will be conducted at multiple medical centers and will continue for up to about three years to monitor treatment effects and safety. During the study, participants will undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, monitoring for adverse events, lab tests, ECGs, and vital sign checks. Researchers will measure objective response rate, duration of response, overall survival, disease control, and progression-free survival. Safety and pharmacokinetic data will also be collected. Participation involves ongoing visits and assessments for up to three years to thoroughly evaluate treatment impact and participant health.
CONDITIONS
Brief Title
A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Research Team
B
BicycleTx Limited
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