Cancer-Killing virus takes on ovarian cancer in first human trial
NCT ID NCT07211659
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new treatment called THEO-260, a virus designed to infect and destroy cancer cells. It is given directly into the abdomen to 18 people with advanced ovarian cancer that no longer responds to platinum chemotherapy. The main goals are to find a safe dose and see if the virus shows any signs of fighting the tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- THEO-260 (a virus that targets and kills cancer cells)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced ovarian cancer that is resistant to standard chemotherapy.
- What could go wrong
- This is a very early, small Phase 1 trial with only 18 participants. The virus may not shrink tumors or could cause side effects like inflammation or cytokine release syndrome.
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 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Sep 2027
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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Female participants only
- 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: * 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 or refractory disease: platinum-resistance is defined as radiological progression within 6 months of last cycle of platinum treatment; platinum refractory disease is defined as radiological progression during the 3 months following the first dose with platinum treatment. * Life expectancy of \> 6 months. * ECOG performance status of 0 or 1. * Measurable disease as per RECIST V1.1. * No clinical history of bowel obstruction in past 3 months or no clinical signs or symptoms of bowel obstruction. Exclusion Criteria: * Prior anti-cancer treatment or Investigational Product within 28 days or 5 half-lives, prior to first dose of THEO-260. * Prior treatment with a group B adenovirus. * Radiation therapy within 4 weeks of first dose of THEO-260 * 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 are eligible. * 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 THEO-260. * Active autoimmune disease that has required systemic treatment in the past 2 years. * Known heart failure New York Heart Association (NYHA) Class 2-4. * Known contra-indications or hypersensitivity to acetominophen. * Known alcohol consumption in excess of 2 units per day. * Left ventricular ejection fraction (LVEF) \<45%, 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 30 days prior to Day 1
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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
1 site. 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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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Mapping the DNA test that decides who gets PARP inhibitors
- Cervical smear DNA may reveal ovarian cancer years before symptoms
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?