Nuzefatide pevedotin (BT5528) for metastatic pancreatic ductal adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, open-label, single-arm multicenter trial gives all participants nuzefatide pevedotin (BT5528), a Bicycle® drug conjugate that targets the EphA2 protein and delivers the cytotoxic payload MMAE. Eligible adults have histologically confirmed metastatic pancreatic ductal adenocarcinoma, measurable disease by RECIST v1.1, ECOG performance status 0–1, and progression on or after one prior line of systemic therapy. The study's main goals are to measure tumor response, document safety and tolerability, and characterize pharmacokinetics, with mandatory tumor tissue available for EphA2 expression and biomarker analyses. Participants are treated and followed at participating clinical sites with scheduled visits for efficacy, safety, and PK assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria

* At least 18 years of age at the time of signature of the informed consent form (or at least 19 years where locally defined as minimum age of consent).
* 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 whose disease has progressed on or after only 1 prior line of therapy or on or after second line therapy with a KRAS inhibitor, 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 in the first-line setting is permitted if there was no intervening treatment prior to enrollment.
* 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 and agree to participate in the study by providing written informed consent.

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

Where it's running

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

Study contacts

• Study coordinator: BicycleTx Limited
• Email: clinicalstudies@bicycletx.com
• Phone: 6179458155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.