drugset / Trial / NCT07365995
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Phase 3
Recruiting
736 enrolled
BioNTech SE
BioNTech (Shanghai) Pharmaceuticals Co., Ltd. · collabDualityBio Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC. The main goals of this study are: * To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival \[rPFS\]). * To find out if BNT324 helps participants live longer overall (overall survival \[OS\]).
Timeline
- Start
- 2026-04-22
- Primary completion
- 2031-02
- Completion
- 2031-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BNT324 | Other / unclassified | — | Intravenous |
| Comparator | Docetaxel | Small molecule | — | Intravenous |
| Comparator | Prednisolone | Other / unclassified | — | Oral |
| Comparator | Prednisone | Other / unclassified | — | Oral |