Virus therapy takes on tough colorectal cancer in new trial
NCT ID NCT07446322
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 11 times
Summary
This study tests whether adding a virus-based drug (pelareorep) to standard chemotherapy can help people with a specific type of advanced colorectal cancer that has stopped responding to initial treatment. About 60 adults whose cancer has spread and has certain genetic features (RAS mutation, MSS) will be randomly assigned to receive either standard chemo plus the virus or standard chemo alone. The goal is to see if the combination shrinks tumors better and improves survival.
Why investors are watching
Oncolytics Biotech is running a Phase 2 trial testing its drug pelareorep added to a standard chemotherapy combination for a hard-to-treat form of colorectal cancer. The trial enrolls 60 patients whose cancer has a RAS mutation and is microsatellite-stable, a group that typically does not respond to newer immunotherapies. For a micro-cap company, this readout is a major value driver because a positive result could validate pelareorep's mechanism in a large patient population.
If it works: A positive result could show that adding pelareorep improves disease control compared to standard care alone. That outcome might support further development and partnerships for the drug in colorectal cancer.
If it fails: Phase 2 trials often fail to show a benefit, and this one has only 60 patients, so the results may be inconclusive or negative. A failure or delay could hurt the company's prospects, since it has few other late-stage assets to fall back on.
AI-written from the trial record. Speculative, and not investment advice.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2030
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.
Inclusion Criteria: * Histologically confirmed cancer of the colon or rectum with documented metastasis * Measurable disease per RECIST v. 1.1 * Not candidates for curative surgery or curative radiation * Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in the metastatic setting or relapsed within 6 months of completing adjuvant oxaliplatin * Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab * Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non dMMR) tumor status per a standard local testing method * Tumor confirmed to harbor a known RAS mutation per a standard local testing method * ECOG performance status of 0 or 1 * Patients must have adequate hematological, renal, and hepatic function * Female patients of childbearing potential must have a negative pregnancy test * Life expectancy of at least 6 months Exclusion Criteria: * Undergone systemic chemotherapy, radiotherapy, or surgery, \<4 weeks before study treatment * Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment * Prior treatment with irinotecan * Symptomatic brain metastases * Active autoimmune disease * Receiving immunosuppressive or myelosuppressive medications * Active, uncontrolled infections * Known HIV infection or active hepatitis B or C that requires anti-viral treatment * History of another primary cancer within the last 3 years except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ * History of allergy or known hypersensitivity to any of the study drugs, study drug classes, * Uncontrolled or severe cardiac disease * Received any vaccine within 28 days prior to first study treatment
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
15 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beacon Cancer Center
RECRUITINGPost Falls, Idaho, 83854, United States
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Central Alabama Research
RECRUITINGHomewood, Alabama, 35209, United States
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Clinical Research Advisors (Beverly Hills)
RECRUITINGBeverly Hills, California, 90211, United States
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Clinical Research Advisors (Downtown LA)
RECRUITINGLos Angeles, California, 90033, United States
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Clinical Research Advisors (Encino)
RECRUITINGEncino, California, 91316, United States
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Clinical Research Advisors (Korea Town)
RECRUITINGKoreatown, California, 90020, United States
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Clinical Research Advisors (West Covina)
RECRUITINGWest Covina, California, 91790, United States
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Clinical Research Advisors (West Hollywood)
RECRUITINGLos Angeles, California, 90048, United States
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Community Health Network
NOT_YET_RECRUITINGIndianapolis, Indiana, 46250, United States
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Emory Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30302, United States
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Gabrail Cancer Center
RECRUITINGCanton, Ohio, 44718, United States
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Karmanos Cancer Institute
RECRUITINGDetroit, Michigan, 48201, United States
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Rutgers Cancer Institute
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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Summit Health Cancer Center
RECRUITINGFlorham Park, New Jersey, 07932, United States
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Washington University School of Medicine
NOT_YET_RECRUITINGSt Louis, Missouri, 63110, United States
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