NCT07211659 Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients
| NCT ID | NCT07211659 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Theolytics Limited |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2026-02-13 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 by the intraperitoneal route to identify a dose that is safe, well tolerated, and exhibits preliminary evidence of anti tumour activity.
Eligibility 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 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
Contact & Investigator
Clinical Trials
STUDY DIRECTOR
Theolytics Ltd
Frequently Asked Questions
Who can join the NCT07211659 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07211659 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07211659 currently recruiting?
Yes, NCT07211659 is actively recruiting participants. Contact the research team at clinicaltrials@theolytics.com for enrollment information.
Where is the NCT07211659 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07211659 clinical trial?
NCT07211659 is sponsored by Theolytics Limited. The principal investigator is Clinical Trials at Theolytics Ltd. The trial plans to enroll 18 participants.
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