A Phase I, Open-label, Dose Finding, Safety, Tolerability and Exploratory Trial of THEO-260 Administered Via an Intraperitoneal Route in Patients With High Grade Serous or Endometrioid Ovarian Cancer
Theolytics Limited
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
* 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 p…
Interventions
- BiologicalTHEO-260
Oncolytic virus
Location
- MD Anderson Cancer CenterHouston, Texas