drugset / Trial / NCT05849298
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium \[177Lu\] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI and bone scans).
Timeline
- Start
- 2024-01-03
- Primary completion
- 2026-12-23
- Completion
- 2026-12-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-PSMA-617 | Other / unclassified | 7.4 g | Intravenous |
| Subject | Apalutamide | Small molecule | — | — |
| Subject | Darolutamide | Other / unclassified | — | — |
| Subject | Enzalutamide | Other / unclassified | — | — |
| Background | 18F-DCFPyL | Diagnostic / imaging agent | 333 mbq | Intravenous |
| Background | 68Ga-PSMA-11 | Diagnostic / imaging agent | 150 mbq | Intravenous |