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.
Written informed consent obtained prior to initiating any trial-specific procedures or assessments.
Male or female patients aged 18 years or over.
Patients with histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic (stage IV) at diagnosis and who have not received any treatment for their pancreatic cancer.
Patients must be able to receive their first dose of VCN-01 ≤6 weeks after their metastatic pancreatic cancer diagnosis.
Unwillingness to complete the trial procedures for geographic, psychiatric, or social reasons.
Palliative radiotherapy for pain is permitted;
Placement of a biliary stent/tube is permitted.
Patients who, in the opinion of the investigator, have symptoms or signs suggesting clinically unacceptable deterioration during the Screening Period.
Single group
VCN-01 oncolytic adenovirus (zabilugene almadenorepvec)
Biological/VaccineThe initial dosing regimen for this study comprises up to three "macrocycles", each of which comprises one dose of VCN-01 followed one week later by 2 cycles of GnP according to standard of care (SoC)
Nab-paclitaxel + Gemcitabine
DrugIV nab-paclitaxel (starting dose 125 mg/m²) followed by IV gemcitabine (starting dose 1,000 mg/m²) according to SoC clinical practice (GnP SoC). Dose modifications and interruptions permitted per prescribing information/SmPC.
Incidence of Treatment-Emergent Adverse Events
Frequency and proportion of participants experiencing AEs/SAEs; descriptive statistics for laboratory values.
Pharmacokinetics (PK) of VCN-01
VCN-01 concentration in blood at predefined time points.
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