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Can a tweaked herpes virus help fight cancer? early trial underway

NCT ID NCT04735978

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 123 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Churchill Hospital

    Oxford, OX3 9DU, United Kingdom

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Laboratoire de Recherche Translationnelle en Immunotherapie (LRTI), Gustave Roussy

    Villejuif, 94805, France

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • START Madrid CIO Clara Campal, Hospital Universitario HM Sanchinarro Unidad de Ensayos Fase I Panta 3

    Madrid, 28050, Spain

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Merseyside, CH63 4JY, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University General Hospital Attikon

    Athens, 12462, Greece

  • University of Athens

    Athens, 11527, Greece

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • Vall d'Hebron Hospital Hospital Universitario Vall d´Hebron (Vall d'Hebron University Hospital)

    Barcelona, 08035, Spain

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