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ACTIVE NOT RECRUITING
NCT07280377
PHASE1/PHASE2

A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab

Sponsor: Oncolytics Biotech

View on ClinicalTrials.gov

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

Interventions

DRUG

Pelareorep

Pelareorep 4.5 x 10\^10 TCID50 via 1-hour IV infusion

DRUG

Atezolizumab

Atezolizumab 840 mg IV infusion

DRUG

Gemcitabine and nab-paclitaxel

Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2)

DRUG

Trifluridine Tipiracil

Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily

DRUG

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