Actively Recruiting
A Phase 2 Study of Nuzefatide Pevedotin (BT5528) in Adults With Metastatic Pancreatic Ductal Adenocarcinoma
Led by BicycleTx Limited · Updated on 2026-04-22
39
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug nuzefatide pevedotin (BT5528) in adults with metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and worsened after one prior treatment. This Phase 2 study aims to assess how well the drug works against tumors, its safety, and how it is processed by the body. Nuzefatide targets a protein called EphA2 often found on cancer cells and delivers a potent anti-cancer agent. Participants will receive nuzefatide pevedotin through intravenous infusions every two weeks. This is an open-label, single-arm trial where all participants receive the study drug, and both participants and their doctors know the treatment being given. The study is conducted at multiple medical centers and includes monitoring for efficacy, safety, and pharmacokinetics. During the study, participants will have measurable disease assessments and other evaluations according to RECIST criteria, with monitoring continuing for up to about three years. Researchers will track tumor response, disease control, survival rates, and side effects, including laboratory and heart function tests. Participants must have adequate organ function and tumor tissue available for biomarker analysis. The total time of involvement depends on individual patient progress and treatment response.
CONDITIONS
Brief 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 informed 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)
- Progressed after only one prior line of therapy with radiographic evidence
- Prior neoadjuvant or adjuvant therapy counts as first line if progression occurred within 6 months
- Prior treatment with KRAS inhibitors is allowed
- Sufficient tumor tissue available for EphA2 and biomarker analysis
- Adequate organ function (blood, kidney, liver)
- Negative pregnancy test for participants who can become pregnant
- Willing and able to follow study procedures
You will not qualify if you...
- Chemotherapy or radiotherapy within 14 days before first study dose
- Experimental treatments within 28 days or 5 half-lives before first study dose
- Prior treatment with taxane therapy or any MMAE-containing agent for pancreatic cancer
- Known high microsatellite instability (MSI-H) eligible for immune checkpoint therapy
- Prior treatment side effects not resolved to Grade 1 per NCI CTCAE v6.0
- Untreated brain metastases
- Additional protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive nuzefatide pevedotin (BT5528) via intravenous infusion every 2 weeks to treat metastatic pancreatic ductal adenocarcinoma.
Visits every 2 weeks for intravenous infusion
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
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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