NCT07211659
Trial of THEO-260 (Administered Via Intraperitoneal Route) in Ovarian Cancer Patients
Recruiting · Phase 1 · Theolytics Limited · registry updated 2026-04-22
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
- 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.