Phase I/IIa trial of THEO-260 in patients with ovarian cancer
Research type
Research Study
Full title
A Phase I/IIa open-label, dose finding, safety, tolerability and exploratory trial of THEO-260 in patients with high grade serous or endometrioid ovarian cancer.
IRAS ID
1007880
Contact name
Rosie Ackerman-Johnson
Contact email
Sponsor organisation
Theolytics Ltd
Research summary
Treatment for ovarian cancer depends on the stage of the disease at diagnosis, but invariably includes surgery (with or without chemotherapy) followed by platinum-based chemotherapy and possibly other targeted therapies. Relapse from remission is common and in the majority of these patients, resistance to platinum occurs with 6 to 12 months of platinum-treatment. These patients are referred to as the platinum-resistant ovarian cancer (PROC) population.
THEO-260 is a type of immunotherapy (an oncolytic virus) that enters the cancer cells and cancer associated cells within a tumour and kills them. It has been selected to target and kill ovarian cancer cells specifically.
The trial aims to: test the safety of THEO-260 and how well the body handles it, see if THEO-260 causes a response in ovarian cancer and helps participants live longer, to find the recommended dose of THEO-260 and to see if THEO-260 helps participants have a better quality of life.
Approximately 28 patients will be enrolled in the trial. Up to 18 participants in the first part on the trial which assesses the safety and determines a recommended dose of THEO-260. 10 participants in the second part of the trial which explores whether THEO-260 causes a response in ovarian cancer.
Participants enrolled in the trial will receive 6 doses of THEO-260 intravenously over a 2-week period and will visit the trial site for observation and follow-up tests until their cancer gets worse or the trial ends.
The clinical trial is funded by Theolytics Limited and will take place at up to 9 trial sites in the UK and Spain.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0084
Date of REC Opinion
15 Apr 2024
REC opinion
Further Information Favourable Opinion