Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT06650605
Brief Summary:
Phase I open-label trial of 123I-ATT001 monotherapy and in combination with treatment therapies in subjects with relapsed glioblastoma.
Detailed Description:
The main goals of this study are to understand if 123I-ATT001 is safe and tolerable to treat participants with relapsed glioblastoma and to determine the maximum tolerated dose that can be given to participants without any unacceptable side effects.
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 a recommended dose (RD) has been declared, a monotherapy expansion cohort will be open at that dose level.
In Part 1 participants will receive a 123I-ATT001 dose, once per week, for four weeks (+ two optional extra cycles).
* Part 2 is a dose expansion study where one dose of 123I-AT001 will be tested in combination with other therapies. Part 2 will begin after the Part 1 has completed and a recommended part 2 dose has been chosen.
The specific details and combination therapies for Part 2 of the study will be added via a protocol amendment at a later date.
Study:
NCT06650605
Study Brief:
Protocol Section:
NCT06650605