RecruitingPhase 2NCT07450859

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

A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma


Sponsor

BicycleTx Limited

Enrollment

39 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BT5528 in patients with metastatic pancreatic ductal adenocarcinoma — the most common and aggressive type of pancreatic cancer that has spread to other parts of the body. BT5528 is an antibody-drug conjugate that targets a protein called EphA2, which is found on many pancreatic cancer cells, and delivers a chemotherapy payload directly to the cancer. **You may be eligible if:** - You are 18 years of age or older - You have been diagnosed with metastatic pancreatic ductal adenocarcinoma, confirmed by biopsy - You have received exactly one prior line of treatment and your cancer has progressed - You have at least one measurable tumor on imaging - You are in good general health (ECOG performance status 0 or 1) - You have sufficient tumor tissue available for biomarker testing - Your kidney, liver, and blood counts are adequate **You may NOT be eligible if:** - You have received prior treatment with taxane drugs (e.g., paclitaxel) for your pancreatic cancer - You have received any drug containing the chemotherapy agent MMAE previously - Your cancer has microsatellite instability-high (MSI-H) status and you are eligible for immunotherapy - You have received chemotherapy or radiotherapy within 14 days before starting the study drug - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGnuzefatide pevedotin (BT5528)

Participants will receive nuzefatide pevedotin (BT5528) via intravenous (IV) infusion every 2 weeks (Q2W)


Locations(1)

Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT07450859


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