Clinical Trial: NCT06004661
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2026-07-10 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: AAA617
- Drug: 68Ga-PSMA-11
Other Study ID Numbers
- CAAA617A12202
- 2023-503925-20-00
- 2023
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2026-07-10 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: AAA617
- Drug: 68Ga-PSMA-11
Other Study ID Numbers
- CAAA617A12202
- 2023-503925-20-00
- 2023