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

PHASE2CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

January 10, 2023

Primary Completion Date

March 28, 2025

Study Completion Date

March 28, 2025

Conditions
Pancreatic AdenocarcinomaMetastatic
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.

Trial Locations (17)

10065

Weill Cornell Medical Center, New York

22031

Virginia Cancer Specialists, Fairfax

28009

Hospital Gregorio Marañon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

39008

Hospital Universitario Marqués de Valdecilla, Santander

40202

University of Louisville - Brown Cancer Center, Louisville

41013

Hospital Universitario Virgen del Rocío, Seville

43221

Martha Morehouse Tower, Columbus

46014

Hospital General Univesitario de Valencia, Valencia

50009

Hospital Miguel Servet, Zaragoza

84112

Huntsman Cancer Institute, University of Utah, Salt Lake City

92663

Hoag Memorial Hospital Presbyterian, Newport Beach

95817

University of California - Davis Cancer Center, Sacramento

08908

Hospital Duran i Reynals (ICO), L'Hospitalet de Llobregat

08035

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Theriva Biologics SL

INDUSTRY