Clinical Trial

A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Newly Diagnosed Metastatic Pancreatic Cancer

Study acronym: VIRAGE2
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if the new administration regimen of VCN-01, given together with the standard chemotherapy drugs gemcitabine and nab-paclitaxel (GnP), is safe and well tolerated. The behaviour of VCN-01 in the organism will be assessed, together with the possible benefits of this administration regimen. This study includes adults with newly diagnosed pancreatic ductal adenocarcinoma (PDAC) that has spread to other parts of the body (stage IV) and who have not received prior treatment for pancreatic cancer. Participants will receive three planned doses of VCN-01, given once every 56 days. Each dose of VCN-01 is followed one week later by two cycles of standard chemotherapy with gemcitabine and nab-paclitaxel. Participants will be monitored throughout the study for safety and side effects.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-07-28
critical Primary endpoint(s) modified 2026-07-24
Trial Details
NCT Number NCT07701486
Lead Sponsor Theriva Biologics SL
Conditions Pancreas Cancer, Metastatic, Pancreas Cancer, Stage IV, Ductal Adenocarcinoma of the Pancreas
Enrollment 6 participants
Start Date 2026-08-03
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-27