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Virus therapy takes on hard-to-treat ovarian cancer

NCT ID NCT06618235

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new treatment called THEO-260, a virus designed to attack cancer cells, in people with advanced ovarian cancer that no longer responds to platinum chemotherapy. About 44 participants will receive different doses of the virus through an IV to find a safe dose and see if it can shrink tumors. The goal is to control the disease, not cure it, as ongoing management is expected.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 44 people

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

Started

Sep 2024

Expected to finish

Jun 2028

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

Female participants only

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: * Confirmed histological diagnosis of advanced high grade serous or endometrioid cancer of the fallopian tube, primary peritoneum or ovary either on archival biopsy or fresh tumour biopsy. * Platinum-resistant disease (radiological recurrence/ progression with 6 months of prior platinum treatment), primary platinum-refractory disease (recurrence/ progression during first line platinum treatment) and patients who are intolerant to or have no available SOC or SOC unacceptable/ unsuitable in the view of the Investigator. * Life expectancy of \> 3 months. * ECOG performance status of 0 or 1. * Measurable disease as per RECIST V1.1. Exclusion Criteria: * Prior anti-cancer treatment within 28 days or 5 half-lives, prior to first dose of THEO-260. * Prior treatment with a group B adenovirus. * Currently enrolled in a clinical trial of an IMP or used any IMP with 5 half-live, prior to first dose of THEO-260. * Radiation therapy within 2 weeks of first dose of THEO-260 and is scheduled to have radiation therapy during participation of trial. * Clinical evidence of cerebral metastases or Central Nervous System (CNS) involvement including leptomeningeal disease. Patients with previous cerebral metastases must have no evidence of progression or haemorrhage after treatment. * Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (as defined as once monthly or more frequently). * Prior pneumonitis or history of interstitial lung disease. * Confirmed QTcF ≥470 ms on screening 12-lead ECG or history of Torsades de Pointes or history of congenital long QT syndrome. * Concomitant medications that prolong the QTc interval and/or increase the risk for Torsades de Pointes. * Patients with active hepatitis infection or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection. * Active infection with tuberculosis. * Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2). * Patients with active human immunodeficiency virus (HIV) infection or known history of HIV infection. * Active infection requiring IV antibiotics within 2 weeks prior to first dose of THEO-260, or long-term oral therapy for systemic infection. * Known contra-indications or hypersensitivity to the excipients of the IMP. * Viral infection during the 2 weeks prior to first dose of THEO-260. * Active autoimmune disease that has required systemic treatment in the past 2 years. * Known risk of renal injury, including those with a past history of acute or sub-acute renal disease. * Known heart failure New York Heart Association (NYHA) Class 2-4. * Known contra-indications or hypersensitivity to the AxMP, paracetamol. * Known alcohol consumption in excess of 2 units per day. * Left ventricular ejection fraction (LVEF) \<50%, unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to trial enrolment or a history of myocarditis. * Arterial oxygen saturation \<92% on room air prior to first dose of THEO-260. * Received any licensed or investigational vaccines within 28 days prior to first dose of THEO-260.

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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.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Centro Integral Oncológico Clara Campal (CIOCC) Hospital

    RECRUITING

    Madrid, Spain

  • Imperial College Healthcare NHS Trust, Hammersmith Hospital

    RECRUITING

    London, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

    RECRUITING

    Oxford, United Kingdom

  • The Beatson West of Scotland Cancer Centre

    RECRUITING

    Glasgow, Scotland, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.