OncoMatch/Clinical Trials/NCT07450859
A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Is NCT07450859 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies nuzefatide pevedotin (BT5528) for pancreatic ductal adenocarcinoma (pdac).
Treatment: nuzefatide pevedotin (BT5528) — 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 or two prior lines of treatment if treated with KRAS inhibitor. 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: EPHA2 expression (testing required; no eligibility threshold specified)
sufficient tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers
Excluded: MSI1 high
Known microsatellite instability-high (MSI-H) status and are eligible for immune checkpoint inhibitor therapy
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — metastatic pancreatic ductal adenocarcinoma
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.
Cannot have received: taxane (paclitaxel)
Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer
Cannot have received: antibody-drug conjugate (MMAE-containing agent)
Prior treatment with any MMAE-containing agent
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Arizona · Phoenix, Arizona
- Mayo Clinic Florida · Jacksonville, Florida
- Mayo Clinic Rochester · Rochester, Minnesota
- Siteman Cancer Center (Washington University School of Medicine) · St Louis, Missouri
- Memorial Sloan Kettering Cancer Center - Main Campus · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07450859 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior taxane, antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require EPHA2?
Yes, EPHA2 expression is a required biomarker for enrollment.
Are patients with MSI1 alterations eligible?
No. MSI1 high is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages