Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
Running, not enrolling · Phase 2
Conditions studied: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
In brief
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.
Key facts
- Study ID
- NCT06004661
- Run by
- Novartis Pharmaceuticals
- People needed
- 23
- Starts
- 2024-04-04
- Expected to finish
- 2026-12-14
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Mount Sinai Hosp Med School — New York, New York, United States
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Vandœuvre-lès-Nancy, France
- Novartis Investigative Site — Essen, Germany
- Novartis Investigative Site — München, Germany
- Novartis Investigative Site — Milan, Italy
- Novartis Investigative Site — Naples, Italy
- Novartis Investigative Site — Granada, Andalusia, Spain
- Novartis Investigative Site — El Palmar, Murcia, Spain
Full record on ClinicalTrials.gov
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