Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer

Summary

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

Conditions

• Pancreatic Adenocarcinoma
• Metastatic

Interventions

DRUG

Nab-paclitaxel

Nab-paclitaxel administered as an IV infusion at a rate of 125 mg/m2. Nab-paclitaxel is administered on Day 1, Day 8 and Day 15 of each 28-day cycles.

DRUG

Gemcitabine

Gemcitabine administered as an IV infusion at a dose of 1,000 mg/m2 immediately after the completion of nab-paclitaxel administration as part of SoC. Gemcitabine is administered on Day 1, Day 8 and Day 15 of each 28-day cycles.

GENETIC

VCN-01

VCN-01 administrated as a single IV infusion at dose 1xE13 viral particles (vp) on Day 1 of the 1st cycle and then again on Day 1 of the 4th cycle (Day 92). On cycle 1 and cycle 4, nab-paclitaxel and gemcitabine administered on Day 8, Day 15 and Day 22.

Sponsors & Collaborators

• Theriva Biologics SL

  lead INDUSTRY

Principal Investigators

• Tara E Seery, MD · Hoag Memorial Hospital Presbyterian

• Edward Kim, MD, PhD · University of California, Davis Cancer Centre

• Vivek R Sharma, MD, FACP · University of Louisville, Brown Cancer Center

• Alana TH Nguyen, MD, PhD · Weill Medical College of Cornell University

• Arjun Mittra, MD · Martha Morehouse Tower

• Christopher Nevala-Plagemann, MD · Hunstman Cancer Institute, University of Utah

• Alexander Spira, MD, PhD · Virginia Cancer Specialists

• Rocío García, MD, PhD · Hospital Universtario 12 de octubre

• Teresa Macarulla, Md, PhD · Hospital Vall d'Hebron

• Andrés Muñoz, MD, PhD · Hospital Gregorio-Marañon

• Carmen Guillén-Ponce, MD, PhD · Hospital Universitario Ramon y Cajal

• Miriam Lobo, MD, PhD · Hospital General Universitario de Valencia

• Roberto Pazo, MD, PhD · Hospital Miguel Servet

• Inmaculada Gallego, MD, PhD · Hospitales Universitarios Virgen del Rocío

• Berta Laquente, MD. PhD · Hospital Duran i Reynals (ICO)

• Eva Martinez de Castro, MD, PhD · Hospital Universitario Marqués de Valdecilla

• Mireya Cazorla, MD, PhD · Hospital Universitario Virgen de la Victoria

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-10

Primary Completion

2025-03-28

Completion

2025-03-28

FDA Drug

Yes

Countries

• United States
• Spain

Study Locations