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New treatment option for Ovarian Cancer
Official title Trial of THEO-260 in Ovarian Cancer Patients
ClinicalTrials.gov ID: NCT06618235
What this study is testing
What is THEO-260?
THEO-260 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Confirmed histological diagnosis of advanced high grade serous or endometrioid cancer of the fallopian tube, primary peritoneum or ovary either on...
- Platinum-resistant disease (radiological recurrence/ progression with 6 months of prior platinum treatment), primary platinum-refractory disease...
- Life expectancy of \> 3 months.
- ECOG performance status of 0 or 1.
- Measurable disease as per RECIST V1.1.
You likely can't join if
- 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...
- Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (as defined as once monthly or more frequently).
See the full eligibility 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...
- Life expectancy of \> 3 months.
- ECOG performance status of 0 or 1.
- Measurable disease as per RECIST V1.1.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
- Glasgow, Scotland, United Kingdom
- London, United Kingdom
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain; Glasgow, Scotland, United Kingdom; London, United Kingdom; Oxford, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.