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A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab
Sponsor: Oncolytics Biotech
Summary
This is an open-label, phase 1/2, multiple-indication platform study to explore safety, potential predictive immune-related biomarkers, and early efficacy (as measured by objective response rate \[ORR; Cohorts 1,2, 4,and 5\] and disease control rate \[DCR; Cohort 3\]) in patients with advanced or metastatic gastrointestinal (GI) tumors. Cohorts 1-4 are not randomized; however, Cohort 5 is comprised of two treatment arms to which patients are randomized in a 1:1 ratio.
Official title: A Phase 1 / 2 Multiple-indication Biomarker, Safety, and Efficacy Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2021-10-27
Completion Date
2028-12-31
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
Pelareorep
Pelareorep 4.5 x 10\^10 TCID50 via 1-hour IV infusion
Atezolizumab
Atezolizumab 840 mg IV infusion
Gemcitabine and nab-paclitaxel
Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2)
Trifluridine Tipiracil
Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily
mFOLFIRINOX Treatment Regimen
mFOLFIRINOX- IV oxaliplatin 85 mg/m2; IV leucovorin 400 mg/m2; IV irinotecan 150 mg/m2; 5-FU 2400 mg/m2 by 46-hour infusion, per local standard of care
Locations (15)
Nationales Centrum für Tumorerkrankungen Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Gemeinschaftspraxis Dr. Med Bernhard Heinreich
Augsburg, Bavaria, Germany
Klinikum der Universität München
München, Bavaria, Germany
Hämatologisch-Onkologische Praxis Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, Free and Hanseatic City of Hamburg, Germany
Krankenhaus Nordwest
Frankfurt am Main, Hesse, Germany
St. Josef-Hospìtal, Bochum
Bochum, North Rhine-Westphalia, Germany
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany
Caritasklinikum Saarbrücken St. Theresia
Saarbrücken, Saarland, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Universität Leipzig
Leipzig, Saxony, Germany
Charité Universitätsklinikum Berlin
Berlin, State of Berlin, Germany