drugset / Trial / NCT04876651
The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only
RandomizedParallel-groupOpen-labelTreatment
Summary
This multinational, multicenter, prospective, randomized, controlled, open label Phase 3 study is designed to investigate and confirm the benefits and risks associated with the PSMA-targeted antibody, 177Lu DOTA rosopatamab administered together with Standard of Care (SoC), as compared to the best SoC alone. The phase 3 will be conducted in patients with metastatic castration-resistant PC (mCRPC) that expresses PSMA and has progressed despite prior treatment with a novel androgen axis drug (NAAD).
Timeline
- Start
- 2023-08-29
- Primary completion
- 2025-07-01
- Completion
- 2025-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-DOTA-rosopatamab | Monoclonal antibody | 2812.96 mbq | Intravenous |
| Comparator | Abiraterone acetate | Small molecule | — | — |
| Comparator | Docetaxel | Small molecule | — | — |
| Comparator | Enzalutamide | Other / unclassified | — | — |
| Comparator | Prednisone | Other / unclassified | — | — |