drugset / Trial / NCT07621692
Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is a phase I dose escalation clinical trial aims to evaluate 161Tb-PSMA-I\&T, a new generation prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) using Terbium-161 to replace Lutetium-177, its safety, dosimetry, biodistribution, pharmacokinetics, and preliminary efficacy in Taiwanese men with metastatic castration-resistant prostate cancer, and to inform future clinical trials.
Timeline
- Start
- 2026-01-01
- Primary completion
- 2030-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 161Tb-PSMA-I&T | Unknown | 4440 mbq | Intravenous |
| Subject | 161Tb-PSMA-I&T | Unknown | 5550 mbq | Intravenous |
| Subject | 161Tb-PSMA-I&T | Unknown | 7400 mbq | Intravenous |