drugset / Trial / NCT06004661

Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function

NCT06004661

Phase 2 Active not recruiting 23 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) administered to participants with progressive PSMA-positive metastatic castration-resistant prostate cancer. The study will also characterize the risk of QT prolongation of AAA617 in this participant population.

Timeline

Start
2024-04-04
Primary completion
2026-12-14
Completion
2026-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-PSMA-617 Other / unclassified 7400 mbq Intravenous