NCT06650605

Phase 1 Open-label Study of 123I-ATT001 in Subjects With Relapsed Glioblastoma

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Theragnostics Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioma Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	123I-ATT001	123I-ATT001

Timeline

• Start date: 2024-07-04
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-10-21
• Last updated: 2026-03-31

Locations

2 sites across 1 country: United Kingdom