Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07280377

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

Led by Oncolytics Biotech · Updated on 2025-12-12

122

Participants Needed

15

Research Sites

374 weeks

Total Duration

On this page

Sponsors

O

Oncolytics Biotech

Lead Sponsor

C

Crolll Gmbh

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG performance status of 0 or 1
  • Measurable lesions according to RECIST v1.1
  • Adequate blood, kidney, and liver function
  • Recovery to grade 1 or baseline for all side effects from previous treatments or surgery
  • Agreement to use effective contraception during and for 6 months after the last study drug dose if of childbearing potential
Not Eligible

You will not qualify if you...

  • Systemic chemotherapy, radiotherapy, or surgery within 4 weeks before study treatment
  • Previous treatment with immune checkpoint inhibitors
  • Uncontrolled or severe heart disease
  • Active, uncontrolled infections
  • Symptomatic brain metastasis
  • Interstitial lung disease with symptoms or signs of activity
  • Autoimmune disease needing systemic treatment in past 2 years
  • Seizure disorder requiring medication
  • Known allergy to study drugs or their ingredients
  • Non-healing wounds, ulcers, or bone fractures within 4 weeks prior to study drug start
  • Pregnant or breastfeeding women
  • Immunodeficiency or ongoing systemic steroid or immunosuppressive therapy
  • Vaccination within 28 days before or during first treatment cycle
  • Life expectancy less than 3 months (Cohorts 1-4)
  • Active Hepatitis B or C needing treatment (Cohorts 1-3)
  • Prior HIV infection with low CD4 count (Cohort 4)
  • Low or absent DPD enzyme activity (Cohort 5)
  • Leptomeningeal disease (Cohort 5)
  • Another primary cancer diagnosis within last 3 years except certain skin, prostate, or cervical cancers (Cohort 5)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Nationales Centrum für Tumorerkrankungen Heidelberg

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

2

SLK-Kliniken Heilbronn GmbH

Heilbronn, Baden-Wurttemberg, Germany, 74078

Actively Recruiting

3

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany, 72076

Actively Recruiting

4

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany, 89081

Actively Recruiting

5

Gemeinschaftspraxis Dr. Med Bernhard Heinreich

Augsburg, Bavaria, Germany, 86150

Actively Recruiting

6

Klinikum der Universität München

München, Bavaria, Germany, 81377

Actively Recruiting

7

Hämatologisch-Onkologische Praxis Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, Germany, 20249

Actively Recruiting

8

Asklepios Kliniken Hamburg GmbH

Hamburg, Free and Hanseatic City of Hamburg, Germany, 22763

Actively Recruiting

9

Krankenhaus Nordwest

Frankfurt am Main, Hesse, Germany, 60488

Actively Recruiting

10

St. Josef-Hospìtal, Bochum

Bochum, North Rhine-Westphalia, Germany, 44791

Actively Recruiting

11

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, Germany, 55131

Actively Recruiting

12

Caritasklinikum Saarbrücken St. Theresia

Saarbrücken, Saarland, Germany, 66113

Actively Recruiting

13

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, Germany, 09116

Actively Recruiting

14

Universität Leipzig

Leipzig, Saxony, Germany, 04103

Actively Recruiting

15

Charité Universitätsklinikum Berlin

Berlin, State of Berlin, Germany, 13353

Actively Recruiting

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Research Team

R

Reference Study ID Number: REO 029 GOBLET

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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