NCT07450859 A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
| NCT ID | NCT07450859 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | BicycleTx Limited |
| Condition | Pancreatic Ductal Adenocarcinoma (PDAC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2026-03-05 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 39 participants in total. It began in 2026-03-05 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07450859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Ductal Adenocarcinoma (PDAC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07450859 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07450859 currently recruiting?
Yes, NCT07450859 is actively recruiting participants. Contact the research team at clinicalstudies@bicycletx.com for enrollment information.
Where is the NCT07450859 trial being conducted?
This trial is being conducted at St Louis, United States, New York, United States, Philadelphia, United States.
Who is sponsoring the NCT07450859 clinical trial?
NCT07450859 is sponsored by BicycleTx Limited. The trial plans to enroll 39 participants.