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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

2025-12-12

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, 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