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

Recruiting now · Phase 1/Phase 2

Conditions studied: Pancreas Cancer, Metastatic, Pancreas Cancer, Stage IV, Ductal Adenocarcinoma of the Pancreas

In brief

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.

Key facts

Study ID

NCT07701486

Run by

Theriva Biologics SL

People needed

6

Starts

2026-08-03

Expected to finish

2027-12-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Unwillingness to complete the trial procedures for geographic, psychiatric, or social reasons.
• Patient has previously received treatment for their metastatic pancreatic cancer with surgery, radiotherapy, chemotherapy or investigational therapy; except that:
• 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.
• Active infection or other serious illness or autoimmune disease at the moment of enrollment. Active infection includes:
• Tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice.
• Patients with past or resolved TB are eligible to participate.
• Hepatitis B Virus (HBV; positive HBV surface antigen [HBsAg] result).
• HBV carriers (patients positive for HBsAg without an active infection) are not eligible to participate;
• Patients requiring antiviral medicines for HBV prophylaxis or treatment are not eligible to participate;
• Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible to participate provided that blood HBV DNA is negative at enrollment.
• Hepatitis C Virus (HCV; positive HCV Ribonucleic acid [RNA]).
• Patients requiring antiviral medicines for HCV prophylaxis or treatment are not eligible to participate;
• Patients positive for HCV antibody are eligible to participate (only if polymerase chain reaction is negative for HCV RNA).
• Human immunodeficiency virus (positive HIV 1/2 antibodies)
• Active infection or other serious illness or autoimmune disease at the moment of enrollment. Active infection includes:
• Tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice.
• Patients with past or resolved TB are eligible to participate.
• Hepatitis B Virus (HBV; positive HBV surface antigen [HBsAg] result).
• HBV carriers (patients positive for HBsAg without an active infection) are not eligible to participate;
• Patients requiring antiviral medicines for HBV prophylaxis or treatment are not eligible to participate;
• Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible to participate provided that blood HBV DNA is negative at enrollment.
• Hepatitis C Virus (HCV; positive HCV Ribonucleic acid [RNA]).
• Patients requiring antiviral medicines for HCV prophylaxis or treatment are not eligible to participate;

Where it is running

• Hospital 12 de Octubre — Madrid, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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