Nab-Paclitaxel + Gemcitabine +/- VCN-01 for Pancreatic Cancer

(VIRAGE Trial)

No longer recruiting at 19 trial locations

Overseen By Michael Kaleko, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VCN Biosciences, S.L.

Must be taking: Nab-Paclitaxel, Gemcitabine

Must not be taking: Anticoagulants, Immunosuppressants

Disqualifiers: Active infection, Chronic liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treat metastatic pancreatic cancer, where the cancer has spread to other parts of the body. Researchers aim to determine if adding a new drug, VCN-01 (an experimental treatment), to the standard treatment of nab-paclitaxel and gemcitabine can improve patient outcomes. The trial includes two groups: one receives only the standard treatment, while the other also receives VCN-01. Suitable candidates for this trial are those diagnosed with metastatic pancreatic cancer who have not yet received other treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on full-dose anticoagulant therapy, you may need to stop it 2 days before and after VCN-01 administration. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VCN-01, combined with standard chemotherapy drugs such as nab-paclitaxel and gemcitabine, is safe for patients with advanced pancreatic cancer. Studies found that most patients tolerated this treatment well. Although some experienced side effects that limited the drug dosage, these instances were rare. Overall, the treatment appeared to extend patients' lives without causing major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for pancreatic cancer, which typically includes nab-paclitaxel and gemcitabine, the investigational treatment VCN-01 acts on the virus-based mechanism for targeting cancer cells. Researchers are excited about VCN-01 because it uses an oncolytic virus that specifically infects and breaks down cancer cells, potentially enhancing the effectiveness of the standard chemotherapy regimen. This approach aims to not only improve the direct attack on cancer cells but also stimulate the body's immune response to fight the cancer more effectively. By introducing this novel mechanism, there's hope for better outcomes in a condition known for its challenging prognosis.

What evidence suggests that this trial's treatments could be effective for metastatic pancreatic cancer?

This trial will compare two treatment approaches for advanced pancreatic cancer. One group will receive the standard chemotherapy regimen of Nab-paclitaxel and Gemcitabine, while another group will receive VCN-01 in addition to the standard chemotherapy. Research has shown that adding VCN-01 to standard chemotherapy can lead to better outcomes. Specifically, patients who received VCN-01 with chemotherapy lived for a median of 10.8 months, compared to 8.6 months with just the standard treatment, marking a significant improvement in survival rates. VCN-01 enhances chemotherapy effectiveness by breaking down the cancer's supportive tissue. Overall, studies have demonstrated that this combination can help patients live longer with this challenging condition. ^{1 4 6 7 8}

Who Is on the Research Team?

Tara E Seery, MD

Principal Investigator

Hoag Memorial Hospital Presbyterian

Edward J. Kim

Principal Investigator

University of California, Davis Cancer Centre

Vivek Sharma, MD, FACP

Principal Investigator

University of Louisville, Brown Cancer Center

Christopher D. Nevala-Plagemann

Principal Investigator

Hunstman Cancer Institute, University of Utah

Alexander Spira, MD

Principal Investigator

Virginia Cancer Specialists

Teresa Macarulla, MD

Principal Investigator

Hospital Vall d'Hebron

Alana TH Nguyen, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Arjun Mittra, MD

Principal Investigator

Martha Morehouse Tower

Rocío García, MD, PhD

Principal Investigator

Hospital Universtario 12 de octubre

Andrés Muñoz

Principal Investigator

Hospital Gregorio-Marañon

Carmen Guillén-Ponce, MD, PhD

Principal Investigator

Hospital Universitario Ramon y Cajal

Miriam Lobo, MD, PhD

Principal Investigator

Hospital General Universitario de Valencia

Roberto Pazo, MD, PhD

Principal Investigator

Hospital Miguel Servet

Inmaculada Gallego, MD, PhD

Principal Investigator

Hospitales Universitarios Virgen del Rocío

Berta Laquente, MD, PhD

Principal Investigator

Hospital Duran i Reynals (ICO)

Eva Martinez de Castro, MD

Principal Investigator

Hospital Universitario Marqués de Valdecilla

Mireya Cazorla, MD, PhD

Principal Investigator

Hospital Universitario Virgen de la Victoria

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage IV metastatic pancreatic adenocarcinoma who haven't had previous systemic treatment. They should have a measurable tumor, an ECOG performance status of 0 or 1, and adequate organ function. Exclusions include certain genetic syndromes, serious illnesses like active infections or liver disease, prior cancers unless in remission for 3+ years, and pregnant or breastfeeding women.

Inclusion Criteria

Written informed consent obtained prior to any study-specific procedures or assessments

Patients with a minimum life expectancy of 5 months

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have a long-term liver condition like cirrhosis or hepatitis.

I have had pneumonitis or interstitial lung disease before.

Any other condition, disease, metabolic dysfunction, 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nab-paclitaxel and gemcitabine as Standard of Care (SoC) with or without VCN-01 in 28-day cycles, with some cycles extending to 35 days for VCN-01 administration

Up to 3 years

Regular visits per cycle, including pre-dose and post-dose assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of overall survival and progression-free survival

Up to 3 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Nab-paclitaxel
• VCN-01

Trial Overview The study is testing the effectiveness of Nab-Paclitaxel and Gemcitabine chemotherapy with or without VCN-01 on patients with metastatic pancreatic cancer. It's a phase IIb trial where participants are randomly assigned to receive either the standard chemo drugs alone or combined with VCN-01.

How Is the Trial Designed?

Group I: Arm 2 -VCN-01 + SoC Experimental Treatment 3 Interventions

A maximum of two (2) doses of VCN-01 administrated as a single IV infusion in combination with nab-paclitaxel and gemcitabine as SoC.

Group II: Arm 1-SoC Active Control 2 Interventions

Nab-paclitaxel and gemcitabine as SoC.

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

VCN Biosciences, S.L.

Lead Sponsor

Trials

5

Recruited

180+

Theriva Biologics SL

Lead Sponsor

Trials

5

Recruited

180+

Citations

1. therivabio.com therivabio.com/press_releases/theriva-biologics-announces-primary-endpoints-for-efficacy-and-safety-achieved-in-virage-phase-2b-clinical-trial-of-vcn-01-with-gemcitabine-nab-paclitaxel-in-newly-diagnosed-metastatic-pancre/

Theriva™ Biologics Announces Primary Endpoints for ... Patients treated with VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy had increased overall survival.

2. onclive.com onclive.com/view/vcn-01-plus-chemo-improves-survival-in-newly-diagnosed-metastatic-pancreatic-cancer

VCN-01 Plus Chemo Improves Survival in Newly ... Patients receiving VCN-01 had a median OS of 10.8 months versus 8.6 months with standard treatment, with a hazard ratio of 0.57.

3. oncodaily.com oncodaily.com/oncolibrary/virage-trial-at-esmo25-pancreatic-cancer

VIRAGE Trial at ESMO 2025: Oncolytic Adenovirus VCN- ... The VIRAGE trial achieved its primary endpoints, demonstrating that the addition of VCN-01 to standard chemotherapy improves overall survival, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8578996/

VCN-01 disrupts pancreatic cancer stroma and exerts ... VCN-01 antitumor activity was superior to gemcitabine alone, and the combination of both treatments was significantly better than either single ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.10046

A phase I dose-escalation study to assess the oncolytic ... VCN01 was safe, being uveitis the most common adverse effect. VCN-01 did not cause retinal toxicity. The response in these heavily pre-treated eyes was ...

6. curetoday.com curetoday.com/view/vcn-01-with-standard-care-boosts-survival-shows-safety-in-pdac

VCN-01 with Standard Care Boosts Survival, Shows Safety ... VCN-01 plus standard chemotherapy and Abraxane proved safe and effective for patients with metastatic pancreatic cancer.

7. therivabio.com therivabio.com/press_releases/theriva-biologics-announces-presentation-of-data-from-vcn-01-retinoblastoma-phase-1-clinical-trial-at-asco-2025-and-investigator-meeting-to-review-topline-data-from-the-virage-phase-2b-trial/

Theriva™ Biologics Announces Presentation of Data from ... This poster presentation provides the investigators with the opportunity to discuss the detailed results on VCN-01 safety and long-term efficacy ...

8. oncnursingnews.com oncnursingnews.com/view/vcn-01-plus-soc-improves-survival-is-safe-in-metastatic-pdac

VCN-01 Plus SOC Improves Survival, Is Safe in Metastatic ... Adding zabilugene almadenorepvec to SOC chemotherapy and nab-paclitaxel was safe and effective in patients with metastatic pancreatic ductal ...