drugset / Trial / NCT07450859

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

NCT07450859

Phase 2 Recruiting 39 enrolled BicycleTx Limited
NaSingle-groupOpen-labelTreatment

Summary

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. 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.

Timeline

Start
2026-03-05
Primary completion
2029-03
Completion
2029-05

Drugs

EvaluationDrugModalityDoseRoute
Subject BT5528 Other / unclassified Intravenous