Nuzefatide pevedotin (BT5528) for metastatic pancreatic ductal adenocarcinoma
A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
This trial tests nuzefatide pevedotin (BT5528), a drug designed to find the EphA2 protein on cancer cells, in adults whose metastatic pancreatic cancer has worsened after one prior systemic treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BicycleTx Limited Industry-sponsored |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07450859 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed metastatic PDAC, measurable disease, ECOG 0–1, life expectancy ≥12 weeks, progression on or after one prior systemic therapy, adequate organ function, and available tumor tissue for EphA2 testing.
Not a fit: Patients with more than one prior systemic therapy, poor organ function or ECOG >1, no available tumor tissue for EphA2 testing, or tumors lacking EphA2 expression are less likely to benefit.
Why it matters
Potential benefit: If successful, the drug could shrink tumors or slow disease progression and offer a new treatment option for patients with metastatic PDAC after one prior therapy.
How similar studies have performed: Other MMAE-based antibody–drug and bicycle drug conjugates have shown activity in several cancers, but EphA2-targeting agents are relatively novel and have limited data specifically in pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * At least 18 years of age at the time of signature of the informed consent form * 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 only 1 prior line of therapy 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 is permitted * 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 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 this trial is running
Philadelphia, Pennsylvania
- 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: 617-945-8155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.