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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
2025-12-12
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, Hamburg, Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, 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