A Phase IIa, Single-arm, Single-center, Open Label, Proof-of-concept Trial Evaluating Increased Frequency Dosing of VCN-01 (Zabilugene Almadenorepvec) in Combination With Nab-Paclitaxel/Gemcitabine (GnP) in Patients With Newly-Diagnosed Metastatic Pancreatic Cancer
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.
• Patients must have at least one measurable tumor lesion that can be imaged for assessments according to RECIST 1.1.
• ECOG performance status of 0 or 1 at enrollment.
• Must be willing to comply with the trial intervention, including prophylactic medications, and procedures.
• Adequate baseline organ function (hematologic, liver, renal) within the 7 days prior to enrollment:
⁃ Hematology:
• Leukocytes ≥3.0x103 mcL
• Absolute neutrophil count ≥1.5x10⁹/L
• Hemoglobin ≥9 g/dL
• Platelets ≥100x10⁹/L
⁃ Coagulation:
• Prothrombin time or international normalized ratio ≤1x upper limit of normal (ULN)
• Activated partial thromboplastin time ≤1.2xULN
⁃ Hepatic:
• Total bilirubin ≤1.5xULN
• ALT and AST ≤2.5xULN (\<5xULN is acceptable if liver metastases are present)
⁃ Renal:
• Serum creatinine ≤1.5xULN; or,
• If serum creatinine \>1.5xULN, an estimated creatinine clearance \>50 mL/min using the Cockcroft and Gault formula
⁃ Nutritional:
⁃ • Serum Albumin ≥30 g/L
⁃ \- Adequate left ventricular ejection fraction (LVEF) ≥ 50% measured by ECHO or MUGA and QT interval corrected by Fridericia (QTcF) assessment ≤ 450 ms for men or ≤ 470 ms for women.