drugset / Trial / NCT06894511
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess safety of combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI and AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the metastic castrate resistant prostate cancer (mCRPC) setting.
Timeline
- Start
- 2025-09-11
- Primary completion
- 2026-10-15
- Completion
- 2026-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-PSMA-617 | Other / unclassified | 7400 mbq | Intravenous |
| Subject | Abiraterone acetate | Small molecule | 160 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 1000 mg | Oral |