CITADEL-123
Research type
Research Study
Full title
CITADEL-123: A Phase I clinical trial to assess the activity of I-123 Poly Adenosine Diphosphate Ribose Polymerase I inhibitor (123I-ATT001) directly administered in subjects with relapsed glioblastoma.
IRAS ID
1006521
Contact name
Greg Mullen
Contact email
Sponsor organisation
Theragnostics Ltd.
Research summary
In this study a type of therapy called targeted radionuclide therapy (TRT) will be used to treat patients with relapsed glioblastoma. The TRT in this study 123I-ATT001, contains two parts. A radioactive part that is radioactive iodine isotope and a chemical part, which can bind to specific targets (proteins) inside cancer cells to kill them while having a much weaker effect on healthy cells.
123I-ATT001 is a new experimental treatment, meaning it has not been approved by any regulatory authorities, such as the UK’s MHRA. This new treatment will only be available for those enrolled in this study. The study consists of two parts. Part 1 is a dose escalation study, where three doses of 123I-ATT001 will be tested, starting with the lowest dose. When the Data Monitoring Committee declare a recommend dose, an additional 8 patients will be recruited at that dose level in Part 1 of the study. In Part 2, one dose of 123I-ATT001 will be tested in a larger group of patients in combination with other therapies. Part 2 will begin after Part 1 has been completed.
123I-ATT001 will be given via an Ommaya reservoir. An Ommaya reservoir is a soft, plastic, dome-shaped device that is placed under the scalp. In Part 1 participants will receive a 123I-ATT001 dose, once per week, for four weeks. Each week is considered a treatment cycle.
Any participant who tolerates the 123I-ATT-001 treatments well and shows clinical benefit (e.g., tumour size reduction) may receive up to two additional treatments (one per week). This will be a joint decision between the doctor and the participant. The doctor may decide to reduce the dose or extend the time between treatment cycles in response to any side effects. However, no further treatments will be given in case any unacceptable side effects are observed.The specific details and combination therapies for Part 2 of the study will be added via a substantial amendment at a later date.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
24/SC/0034
Date of REC Opinion
23 Feb 2024
REC opinion
Further Information Favourable Opinion