Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer

Exclusion Criteria

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• •1. Patients not willing to complete the study procedures for geographic, psychiatric, or social reasons.
• •However, the following patients are eligible to participate in the study:
• •o Patients with past or resolved TB are eligible;
• •o Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[HBcAb\] and absence of HBsAg) are eligible. Blood HBV DNA must be obtained and must be negative in these patients prior to treatment;
• •o Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• •3. Treatment with live attenuated vaccines in the last 3 weeks and with the adenovirus type-5 (Ad5)-based COVID-vaccine in the last 12 weeks before the administration of study treatment.
• •4. Known chronic liver disease (liver cirrhosis, chronic hepatitis). If there is a suspicion of hepatic fibrosis, a FibroScan must be performed; patients with a value ≥9.5 kPa will be excluded. Note: Transient elastography (Fibroscan) is a non-invasive method for the assessment of hepatic fibrosis.
• •5. Treatment with another investigational agent within five of that treatment's half-lives prior to infusion of study treatment.
• •6. Viral syndrome diagnosed during the 2 weeks before start of study treatment administration.
• •7. Chronic immunosuppressive therapy and/or disease modifying therapy, except inhaled corticosteroids, and oral or IV corticosteroids with a dose lower than 10 mg prednisone or equivalent/day (exception: dexamethasone 1 mg/day as maximum).
• •8. Concurrent malignant hematologic or solid disease. Patients with a prior history of cancer can be allowed if complete remission for at least 3 years.
• •9. Patients in close contact (e.g., living in same house) with immunosuppressed patients (i.e., patients with chronic immunosuppressive therapy including high dose of corticosteroids, patients with acquired immunodeficiency syndrome (AIDS), and other chronic immune system diseases).
• •10. Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency.
• •11. A female patient, who is pregnant or lactating.
• •12. Patients receiving full-dose anticoagulant therapy or in whom these therapies cannot be withdrawn 2 days prior and 2 days after VCN-01 administration. Patients with uncontrolled coagulopathy should be excluded.
• •13. Untreated brain metastases and/or leptomeningeal carcinomatosis with progressive symptoms despite corticosteroid coverage. Patients with brain metastases with stable symptoms can be included.
• •14. Any other condition, disease, metabolic dysfunction (e.g., uncontrolled diabetes mellitus), active or uncontrolled infection/inflammation, physical examination finding, mental state or clinical laboratory finding that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.
• •15. Patients with previous pneumonitis or interstitial lung disease.
• •16. Patients with pre-existing sensory neuropathy \>G1.
• •17. Patients with known risk factors for bowel perforation.
• •18. Patients with QT interval corrected by Fridericia (QTcF) assessment \>450 ms for men or \>470 ms for women and left ventricular ejection fraction (LVEF) evaluation less than 50% measured by ECHO or multigated acquisition scan.
• •19. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• •20. Subjects, for whom first line treatment options other than the combination Gemcitabine/Nab-Paclitaxel are recommended by the investigator.