๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-11

A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (NCT07450859)

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

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: BicycleTx Limited

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 or two prior lines of treatment if treated with KRAS inhibitor. 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.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Arizona โ€” Phoenix, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (6 Sites)

  • Mayo Clinic Arizona โ€” Phoenix, Arizona
  • Mayo Clinic Florida โ€” Jacksonville, Florida
  • Mayo Clinic Rochester โ€” Rochester, Minnesota
  • Siteman Cancer Center (Washington University School of Medicine) โ€” St Louis, Missouri
  • Memorial Sloan Kettering Cancer Center - Main Campus โ€” New York, New York
  • Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office โ€” Philadelphia, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 945-8155

Email: clinicalstudies@bicycletx.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—