Actively Recruiting
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
Eligibility Criteria
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
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
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
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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