Actively Recruiting
A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Led by BicycleTx Limited · Updated on 2026-04-22
39
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Failed only 1 prior line of therapy with evidence of radiographic progression
- Neoadjuvant or adjuvant systemic therapy may count as first line if progression occurred less than 6 months from end of therapy
- Prior treatment with KRAS inhibitors is permitted
- Sufficient tumor tissue available for analysis of EphA2 expression and other biomarkers
- Adequate hematologic, renal, and hepatic organ function
- Negative pregnancy test for participants of childbearing potential
- Willing and able to comply with protocol and study procedures
You will not qualify if you...
- Chemotherapy or radiotherapy within 14 days before first dose of study treatment
- Experimental treatments within 28 days or 5 half-lives, whichever is longer, before first dose
- Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer
- Prior treatment with any MMAE-containing agent
- Known microsatellite instability-high (MSI-H) status and eligibility for immune checkpoint inhibitor therapy
- Prior toxicities must have resolved to Grade 1 per NCI CTCAE v6.0
- Untreated central nervous system (CNS) metastases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
B
BicycleTx Limited
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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