NCT07280377Active, not recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 27 Oct 2021
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- Oncolytics Biotech
- Diseases
- Pancreatic cancer
- NCT number
- NCT07280377
- EU CT number
- 2024-515936-62-00
- EudraCT number
- 2020-003996-16
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 122
- From 27 Oct 2021 to the primary completion date, 30 Jul 2027
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Undergone systemic chemotherapy, radiotherapy, or surgery, \<4 weeks before study treatment.
- Received previous treatment with immune checkpoint inhibitors
- A non-healing wound, non-healing ulcer, or non-healing bone fracture within 4 weeks prior to the start of study drug.
- A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy
- Any vaccine within 28 days prior to first treatment or during the first cycle of study treatment.
- In Cohort 4: Prior HIV infection if the CD4+ T cell is \<300 cells/µl
Other illness
- Uncontrolled or severe cardiac disease
- Active, uncontrolled infections
- Interstitial lung disease with symptoms or signs of activity.
- Autoimmune disease that has required systemic treatment in the past 2 years with disease modifying agents, corticosteroids, or immunosuppressive drugs.
- A seizure disorder that requires pharmacotherapy.
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- In Cohort 1, 2, 3: known active Hepatitis B (HBV) or Hepatitis C (HCV) infection that requires anti-viral treatment.
- In Cohort 5: Known leptomeningeal disease.
- In Cohort 5: History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ
Other
- Symptomatic brain metastasis
- Women who are pregnant or breastfeeding.
- In Cohort 1, 2, 3, 4: Life expectancy less than 3 months
- In Cohort 5: Known low or absent dihydropyrimidine dehydrogenase (DPD) activity.
Criteria the registry did not label
- Cohorts 1-5 Inclusion Criteria:
- ECOG performance status of 0 or 1
- Have measurable lesions per RECIST v1.1
- Patients must have adequate hematological, renal, and hepatic function
- Have recovered to ≤grade 1 or baseline for all adverse events (AEs) due to previous therapies or surgeries.
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use a highly-effective form(s) of contraception and to continue its use for 6 months after the last dose of study drug.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gemeinschaftspraxis Dr. Med Bernhard Heinreich Coordinator of this site? Confirm its status | Augsburg | Germany | Unknown status |
| Charite- Universitätsklinikum Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| St. Josef-Hospìtal, Bochum Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Unknown status |
| Krankenhaus Nordwest Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| Hämatologisch-Onkologische Praxis Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Nationales Centrum für Tumorerkrankungen Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| SLK-Kliniken Heilbronn GmbH Coordinator of this site? Confirm its status | Heilbronn | Germany | Unknown status |
| Universität Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Universitätsmedizin Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Klinikum der Universität München Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Caritasklinikum Saarbrücken St. Theresia Coordinator of this site? Confirm its status | Saarbrücken | Germany | Unknown status |
| Universitätsklinikum Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Universitätsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.