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Looking for participantsPhase1/Phase2

Trial of THEO-260 in Ovarian Cancer Patients

Sponsor: Theolytics Limited

NCT ID: NCT06618235

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
THEO-260 (biological)
How long the study runs
Study runs about 45 months (dates as stated)
About the drug or intervention
THEO-260 — biological: Oncolytic Virus
Patient visit burden
Not specified by the sponsor

In plain English

This trial is testing a treatment called THEO-260 in people with ovarian cancer. It is for those whose cancer is advanced, of a type called high grade serous or endometrioid, affecting the ovary, fallopian tube or peritoneum (the lining of the tummy). The trial is run by Theolytics Limited.

Who can take part

  • A confirmed diagnosis of advanced high grade serous or endometrioid cancer of the ovary, fallopian tube or peritoneum, shown by a biopsy (tissue sample)
  • Cancer that has come back or got worse within 6 months of platinum chemotherapy, during it, or platinum treatment is not suitable for you
  • Expected to live more than 3 months
  • Able to carry out light activity (performance status score of 0 or 1)
  • Cancer that can be measured on scans

Who may not be able to

  • Cancer treatment in the last 28 days or 5 half-lives before the first dose of THEO-260
  • Previous treatment with a group B adenovirus (a type of virus)
  • Currently taking part in another clinical trial of a medicine, or recent use of one
  • Radiotherapy within 2 weeks of the first dose, or radiotherapy planned during the trial
  • Cancer spread to the brain or spinal cord that is currently causing problems, unless treated and stable
  • Fluid build-up around the lungs or heart needing drainage once a month or more often
  • Past inflammation of the lungs (pneumonitis) or lung disease
  • A heart tracing showing a long QT interval, or a history of certain heart rhythm problems
  • Taking medicines that prolong the QT interval or raise the risk of a serious rhythm problem
  • Hepatitis B or C infection (active, or past hepatitis B)
  • Active tuberculosis
  • Active COVID-19 infection
  • HIV infection
  • Active infection needing antibiotics into a vein in the last 2 weeks, or long-term infection treatment
  • Allergy or known reason not to take the trial medicine's ingredients
  • A viral infection in the 2 weeks before the first dose
  • Active autoimmune disease treated with body-wide treatment in the past 2 years
  • Known risk of kidney injury or past kidney disease
  • Heart failure (New York Heart Association class 2 to 4)
  • Allergy or known reason not to take paracetamol
  • Drinking more than 2 units of alcohol a day
  • Heart problems such as weak heart pumping, unstable angina, serious rhythm problems, heart attack in the last 6 months, or heart muscle inflammation
  • Low oxygen levels in the blood (below 92%) before the first dose
  • Any vaccine (licensed or being tested) in the 28 days before the first dose

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Number of visits, how long the trial lasts and what taking part involves: not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
44
Started
2024-09-24
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for ovarian cancer
  • • Phase1/Phase2 - 44 participants
  • • A research study evaluating a new oncolytic virus, THEO-260, in patients with advanced ovarian cancer

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with ovarian cancer
  • • Female only

Where?

  • • Glasgow - The Beatson West of Scotland Cancer Centre
  • • London - Imperial College Healthcare NHS Trust, Hammersmith Hospital
  • • Oxford - Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

A research study evaluating a new oncolytic virus, THEO-260, in patients with advanced ovarian cancer. The trial will investigate different doses of THEO-260 administered intravenously to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity.

Ovarian Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only
  • How fit you need to be: ECOG 0 or better

What the study is looking for

  • ✓Confirmed histological diagnosis of advanced high grade serous or endometrioid cancer of the fallopian tube, primary...
  • ✓Life expectancy of \> 3 months.
  • ✓Fit enough for normal activity (ECOG 0) or 1.
  • ✓cancer that can be measured on scans as per (standard scan measurements).

Who cannot take part

  • ✗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.
  • ✗radiotherapy within 2 weeks of first dose of THEO-260 and is scheduled to have radiotherapy during...
  • ✗Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (as defined as once...
See the full criteria
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.

Where Is This Study? (3 UK sites)

The Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Recruiting
Site contact (verified)

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, United Kingdom

Recruiting
Site contact (verified)

Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

Oxford, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Clinical Trials

Sponsor contact

CONTACT

+441865607020 clinicaltrials@theolytics.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04