Can a tweaked herpes virus help fight cancer? early trial underway
NCT ID NCT04735978
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a genetically modified herpes virus called RP3, alone or combined with the immunotherapy drug nivolumab, in 123 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety and find the best dose. Participants must have a tumor that can be measured and agree to biopsies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RP3 (a genetically modified herpes simplex virus) and nivolumab (an immunotherapy drug)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is a very early Phase 1 trial focused on safety and dosing, not yet on effectiveness. The virus and drug combination may cause side effects or fail to shrink tumors.
Why investors are watching
Replimune is testing RP3, an experimental therapy, in 123 adults with advanced solid tumors. This Phase 1 trial checks whether RP3 is safe and tolerable on its own and with an anti-PD1 drug, and it aims to find the right dose for later studies. For a small company, this readout is a key test of whether RP3 works well enough to move forward.
If it works: If the trial shows RP3 is safe and tolerable, Replimune could advance the drug to Phase 2 testing. That progress would validate the company's main pipeline asset and support its future development plans.
If it fails: If RP3 causes serious side effects or fails to show a tolerable dose, the trial could be delayed or stopped. Many Phase 1 cancer trials fail, and such an outcome would hurt Replimune's prospects because the company depends heavily on this drug.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 123 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Nov 2026
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: * Patients with advanced or metastatic non-neurological solid tumors, who have progressed on standard therapy or cannot tolerate standard therapy, or for whom there is no standard therapy preferred to enrollment in a clinical study * All patients must consent to provide archival tumor biopsy samples within 12 months, or a fresh tumor biopsy is needed. Patients must also consent to provide on treatment biopsies as per protocol * At least one measurable tumor ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes) * At least one injectable tumor ≥ 1 cm in longest diameter or injectable tumors which in aggregate are ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes * Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Note: Predefined inclusion criteria may apply for each additional expansion cohort. Exclusion Criteria: * Prior treatment with an oncolytic virus therapy * History of viral infections according to the protocol * Systemic infection requiring intravenous (IV) antibiotics * Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis) * Requires intermittent or chronic use of systemic antivirals a. Hepatocellular carcinoma patients with a diagnosis of hepatitis B must be off antiviral therapy for at least 4 weeks prior to enrollment . Hepatocellular carcinoma patients with a history of or ongoing hepatitis C infection must have completed treatment for hepatitis C at least 1 month prior to study enrollment and hepatitis * History of interstitial lung disease * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Additional Exclusion Criteria for Patients Enrolled in Part 2 (Expansion Cohorts): * History of life-threatening toxicity related to prior immune treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways * Treatment with botanical preparations within 2 weeks prior to treatment. * Active, known, or suspected autoimmune disease requiring systemic treatment. * History of interstitial lung disease. * Severe hypersensitivity to another monoclonal antibody. * Has received prior radiotherapy within 2 weeks of start of study treatment. * Has received a live vaccine within 28 days prior to the first dose of study treatment. * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * History of myocarditis or congestive heart failure within 6 months of screening. * Has a serious or uncontrolled medical disorder. * Has a QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 480 msec, except for right bundle branch block.
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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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Churchill Hospital
Oxford, OX3 9DU, United Kingdom
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Hospital Clinic Barcelona
Barcelona, 08036, Spain
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Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
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Laboratoire de Recherche Translationnelle en Immunotherapie (LRTI), Gustave Roussy
Villejuif, 94805, France
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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START Madrid CIO Clara Campal, Hospital Universitario HM Sanchinarro Unidad de Ensayos Fase I Panta 3
Madrid, 28050, Spain
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The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Merseyside, CH63 4JY, United Kingdom
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The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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University General Hospital Attikon
Athens, 12462, Greece
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University of Athens
Athens, 11527, Greece
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University of Iowa
Iowa City, Iowa, 52242, United States
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Vall d'Hebron Hospital Hospital Universitario Vall d´Hebron (Vall d'Hebron University Hospital)
Barcelona, 08035, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors