RecruitingPhase 1Phase 2NCT07280377

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

A Phase 1 / 2 Multiple-indication Biomarker, Safety, and Efficacy Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab


Sponsor

Oncolytics Biotech

Enrollment

122 participants

Start Date

Oct 27, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing combinations of two drugs — pelareorep (a cancer-fighting virus) and atezolizumab (an immunotherapy) — in people with advanced gastrointestinal cancers including colorectal, pancreatic, stomach, and biliary cancers. **You may be eligible if...** - You have advanced or metastatic gastrointestinal cancer - You are in good physical condition (ECOG 0 or 1) - You have measurable disease on scan - Your blood, kidney, and liver function are adequate - You have recovered from side effects of previous treatments - You are willing to use contraception if applicable **You may NOT be eligible if...** - You received chemotherapy, radiation, or surgery within the past 4 weeks - You have already been treated with immune checkpoint inhibitors (such as PD-1/PD-L1 drugs) - You have symptomatic brain metastases - You have active autoimmune disease requiring treatment - You have active, uncontrolled infections or serious heart disease - You have active interstitial lung disease - You are pregnant or breastfeeding - You have received a vaccine within 28 days before starting treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPelareorep

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

DRUGAtezolizumab

Atezolizumab 840 mg IV infusion

DRUGGemcitabine and nab-paclitaxel

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

DRUGTrifluridine Tipiracil

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

DRUGmFOLFIRINOX 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

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NCT07280377


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