Virus-Immunotherapy cocktail takes on tough GI cancers
NCT ID NCT07280377
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-stage trial is testing a combination of pelareorep (a reovirus) and atezolizumab (an immunotherapy) along with standard chemotherapies in people with advanced anal or pancreatic cancers. The study aims to find safe doses, look for biomarkers that predict response, and measure early signs of tumor shrinkage or disease control. About 122 participants are enrolled across five groups, each receiving different drug combinations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pelareorep and atezolizumab (plus chemotherapy drugs like gemcitabine, nab-paclitaxel, trifluridine/tipiracil, or mFOLFIRINOX)
- What this could lead to
- If successful, this could point toward new treatment options for advanced gastrointestinal cancers that are hard to treat.
- What could go wrong
- This is an early phase 1/2 study with a small number of participants, so results may not confirm effectiveness. The combination therapies also carry risks of side effects from both the drugs and chemotherapy.
Why investors are watching
Oncolytics Biotech is running a phase 1/2 trial of its drug pelareorep combined with atezolizumab in patients with advanced gastrointestinal cancers. For a micro-cap company, this trial's early efficacy and safety data could determine whether its lead drug has a future in a large cancer market. The trial also tests biomarkers, which could help identify which patients respond best.
If it works: A positive result could show that the combination shrinks tumors or controls disease in a meaningful share of patients. That evidence could support further development and partnerships, giving the company a clearer path forward.
If it fails: The trial could fail to show enough benefit or reveal safety problems, which is common in early-stage cancer studies. A failure or delay could hurt the company's prospects, since it has few other assets to fall back on.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 122 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Exclusion Criteria: * Undergone systemic chemotherapy, radiotherapy, or surgery, \<4 weeks before study treatment. * Received previous treatment with immune checkpoint inhibitors * Uncontrolled or severe cardiac disease * Active, uncontrolled infections * Symptomatic brain metastasis * 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. * A non-healing wound, non-healing ulcer, or non-healing bone fracture within 4 weeks prior to the start of study drug. * Women who are pregnant or breastfeeding. * 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. Exclusion Criteria: * In Cohort 1, 2, 3, 4: Life expectancy less than 3 months * In Cohort 1, 2, 3: known active Hepatitis B (HBV) or Hepatitis C (HCV) infection that requires anti-viral treatment. * In Cohort 4: Prior HIV infection if the CD4+ T cell is \<300 cells/µl * In Cohort 5: Known low or absent dihydropyrimidine dehydrogenase (DPD) activity. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asklepios Kliniken Hamburg GmbH
Hamburg, Free and Hanseatic City of Hamburg, 22763, Germany
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Caritasklinikum Saarbrücken St. Theresia
Saarbrücken, Saarland, 66113, Germany
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Charité Universitätsklinikum Berlin
Berlin, State of Berlin, 13353, Germany
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Gemeinschaftspraxis Dr. Med Bernhard Heinreich
Augsburg, Bavaria, 86150, Germany
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Hämatologisch-Onkologische Praxis Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20249, Germany
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Klinikum Chemnitz gGmbH
Chemnitz, Saxony, 09116, Germany
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Klinikum der Universität München
München, Bavaria, 81377, Germany
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Krankenhaus Nordwest
Frankfurt am Main, Hesse, 60488, Germany
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Nationales Centrum für Tumorerkrankungen Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
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SLK-Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, 74078, Germany
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St. Josef-Hospìtal, Bochum
Bochum, North Rhine-Westphalia, 44791, Germany
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Universität Leipzig
Leipzig, Saxony, 04103, Germany
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Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
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Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
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Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
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