drugset / Trial / NCT07621692

Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T

NCT07621692 ↗

Phase 1 Recruiting 12 enrolled National Taiwan University Hospital
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

EvaluationDrugModalityDoseRoute
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

Indications