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

(VIRAGE Trial)

Recruiting at 17 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

112 Participants Needed

Trial Summary

What is the purpose of this trial?

A phase IIb, open-label, randomized study of Nab-Paclitaxel and Gemcitabine and plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+