Safety Study of VCN-01 with nab‑Paclitaxel and Gemcitabine in Newly Diagnosed Metastatic Pancreatic Cancer Patients

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What is this study about?

The study focuses on metastatic pancreatic adenocarcinoma, a type of cancer that starts in the pancreas and has spread to other parts of the body. Participants will receive a combination of an experimental gene‑based therapy called VCN-01 (zabilugene almadenorepvec) and the standard chemotherapy drugs known as nab‑Paclitaxel/Gemcitabine (GnP). VCN-01 is a specially engineered virus that carries an enzyme to help the chemotherapy work better, and it is given by an intravenous (through a vein) infusion.

The purpose of the trial is to see whether giving VCN-01 together with GnP is safe and well‑tolerated, and to understand how the virus behaves in the body by measuring its genetic material in the blood.

Participants will start the treatment with a first dose of VCN-01 at the same time as the initial chemotherapy cycle. The virus dose will be repeated about every eight weeks, for a total of three doses, while chemotherapy cycles continue as usual. Throughout the study, regular visits will include blood tests to check for any side effects and imaging scans to see how the cancer is responding.

1 baseline assessment

after joining the trial, baseline evaluations are performed. these include medical history review, physical examination, laboratory tests, and imaging studies to confirm the diagnosis of metastatic pancreatic adenocarcinoma.

blood samples are collected for future analysis of viral genome levels and antibody responses.

2 first treatment cycle

on day 0 the first vcn-01 dose is given by intravenous infusion. the dose is 10000000000000 vector genomes per milliliter, prepared as a concentrate for infusion.

the same day, chemotherapy with nab-paclitaxel and gemcitabine (referred to as GnP) is started according to the standard schedule used for this disease.

3 post‑first dose monitoring

following the first infusion, safety checks are performed regularly, including vital signs, laboratory tests, and assessment of any adverse effects.

blood is drawn to measure the amount of viral genome from vcn-01 and to evaluate immune response.

4 second vcn-01 dose

56 days after the first infusion, a second identical dose of vcn-01 (10000000000000 vector genomes/mL) is administered by intravenous infusion.

chemotherapy with nab-paclitaxel and gemcitabine continues according to the same schedule as before.

5 post‑second dose monitoring

safety and tolerability are evaluated again with clinical examinations and laboratory tests.

additional blood samples are taken to track viral genome levels and antibody changes.

6 third vcn-01 dose

56 days after the second infusion (day 112 of the trial), the third and final dose of vcn-01 is given, using the same dose and infusion method.

the ongoing nab-paclitaxel and gemcitabine chemotherapy continues as previously scheduled.

7 final monitoring and follow‑up

after the third dose, regular assessments are performed to evaluate overall safety, response of the cancer, and any lasting effects.

the trial continues with scheduled visits until the study end date, during which imaging and laboratory tests are repeated to determine disease status.

Who Can Join the Study?

Written informed consent must be signed before any study procedures begin.
You must be a man or woman who is at least 18 years old.
You need a diagnosis of metastatic pancreatic adenocarcinoma (stage IV) that has not been treated before with the standard chemotherapy called gemcitabine/nab‑paclitaxel.
You must have at least one tumor that can be measured on a scan, using a system called RECIST 1.1 (a standard way doctors track tumor size).
Your overall health level, measured by the ECOG performance status, must be 0 or 1 (meaning you are fully active or able to carry out light work).
You must be willing to follow the study’s treatment schedule, including any preventive medicines and required study visits.
Your blood and organ function must be within safe limits in the week before you join the study:
- Blood cells: white blood cells ≥3.0 × 10³/µL, neutrophils ≥1.5 × 10⁹/L, hemoglobin ≥9 g/dL, platelets ≥100 × 10⁹/L.
- Blood clotting: prothrombin time/INR and activated partial thromboplastin time must be normal or only slightly above normal.
- Liver: bilirubin ≤1.5 × normal, and liver enzymes ALT and AST ≤2.5 × normal (up to 5 × normal is allowed if liver metastases are present).
- Kidneys: creatinine ≤1.5 × normal, or if higher, a calculated creatinine clearance >50 mL/min (a measure of how well the kidneys clear waste).
- Nutrition: serum albumin ≥30 g/L.
Your heart must work well: a left ventricular ejection fraction (LVEF) of at least 50% (measured by an ultrasound test called an ECHO or a scan called MUGA) and a corrected QT interval (QTcF) of ≤450 ms for men or ≤470 ms for women (both are measurements of heart rhythm safety).

Who Cannot Join the Study?

Not willing to complete all study visits or procedures because of where you live, mental health issues, or personal circumstances.
Having pre‑existing sensory nerve damage that is worse than mild (grade 1) – this is called sensory neuropathy and can cause tingling or numbness.
Having a blood clot in a deep vein (deep vein thrombosis), a clot in the lungs (pulmonary embolism), or an arterial clot discovered during the screening period.
Having an uncontrolled problem with blood clotting, known as coagulopathy.
Any other medical problem (for example, uncontrolled diabetes, an active infection, or a mental health condition) that could make the study unsafe for you or could prevent you from following the study rules.
Being pregnant or breastfeeding. Women who could become pregnant must agree to use a highly effective birth‑control method, and men must agree to use condoms.
Having received a live‑attenuated vaccine (a vaccine that contains a weakened form of a germ) within the 3 weeks before the study drug is given.
Having received a COVID‑19 vaccine that uses adenovirus type‑5 (Ad5) within the 12 weeks before the study drug is given.
Having taken another experimental (investigational) medicine within five half‑lives of that medicine before randomisation. A half‑life is the time it takes for half of a drug to leave the body.
Being on long‑term medicines that suppress the immune system, except for inhaled steroids or low‑dose oral/IV steroids (less than 10 mg prednisone‑equivalent per day or up to 1 mg dexamethasone per day).
Having a known allergy or severe reaction to any of the study drugs or any of the inactive ingredients in the drugs.
Having already been treated for metastatic pancreatic cancer with surgery, radiation, chemotherapy, or another experimental therapy, except for pain‑relieving radiation or placement of a biliary stent/tube.
If the doctor believes that a first‑line treatment other than the combination of gemcitabine and nab‑paclitaxel would be better for you.
Showing signs or symptoms that suggest your condition is getting unacceptably worse during the screening period.
Having an active infection or serious illness or an autoimmune disease at the time of enrolment. This includes:
- Active tuberculosis (TB) – a bacterial lung infection.
- Active hepatitis B (positive surface antigen) or needing medicines for hepatitis B.
- Active hepatitis C (positive RNA) or needing medicines for hepatitis C.
- HIV infection – even if the virus is undetectable, it is still an exclusion.
Having a chronic liver disease such as cirrhosis, liver fibrosis, or chronic hepatitis, except for fatty liver disease if your liver enzyme levels meet the study’s safety limits.
Having another current cancer of the blood or solid organs, except if you had a previous cancer that has been completely gone (remission) for at least three years.
Having Li‑Fraumeni syndrome or a known inherited problem with the retinoblastoma protein pathway, which are genetic conditions that increase cancer risk.
Having untreated brain metastases (cancer that has spread to the brain) or leptomeningeal carcinomatosis (cancer spread to the membranes around the brain and spinal cord) that are getting worse despite steroid treatment, unless the brain lesions are stable.
Having had previous pneumonitis (inflammation of the lungs) or interstitial lung disease (a group of lung disorders that cause scarring).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hospital 12 de Octubre	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.06.2026

Trial locations

Investigated drugs:

Genetically Modified Human Adenovirus Encoding Human Ph20 Hyaluronidase

VCN-01 is a specially engineered virus that has been modified to carry a human enzyme called PH20 hyaluronidase. The virus is given by an IV infusion and works by breaking down a thick, jelly‑like substance (hyaluronic acid) that often surrounds pancreatic cancer cells. By loosening this barrier, the virus may help other cancer medicines reach the tumor more easily and also stimulate the body’s immune response against the cancer. This product is being studied as a new treatment option for patients with newly diagnosed metastatic pancreatic cancer.

nab-Paclitaxel is a chemotherapy drug that contains the cancer‑killing agent paclitaxel bound to a protein called albumin. The albumin helps the drug travel through the bloodstream and enter cancer cells more efficiently. It is given by IV infusion and works by stopping cancer cells from dividing and growing. In this trial, nab‑Paclitaxel is used together with other drugs to try to improve treatment results for pancreatic cancer.

Gemcitabine is another chemotherapy medicine that interferes with the building blocks needed for DNA, which stops cancer cells from copying themselves and growing. It is also administered through an IV infusion. Gemcitabine is a standard part of treatment for pancreatic cancer, and in this study it is combined with nab‑Paclitaxel and VCN‑01 to see if the combination can be safer and work better for patients.

Investigated diseases:

Adenocarcinoma pancreas

Metastatic pancreatic adenocarcinoma – Metastatic pancreatic adenocarcinoma is a cancer that starts in the glandular cells of the pancreas and has spread to other parts of the body. The disease begins with abnormal growth of cells in the pancreas, forming a tumor that can block normal pancreatic functions. Over time, cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system to distant organs such as the liver, lungs, or peritoneum. As the tumor spreads, it can cause new growths that continue to enlarge and interfere with the normal activity of affected organs. The spread of cancer cells often leads to an increase in the overall amount of tumor tissue throughout the body.

Trial ID:

2026-525566-21-00

Protocol code:

P-VCNA-004

Trial Phase:

Therapeutic exploratory (Phase II)

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Safety Study of VCN-01 with nab‑Paclitaxel and Gemcitabine in Newly Diagnosed Metastatic Pancreatic Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?