Abiraterone Acetate in Combination With Tildrakizumab
Summary
The purpose of this study is to find out the side effects and safety of a combination of the anti-IL23 targeting monoclonal antibody tildrakizumab in combination with abiraterone acetate in men with metastatic castration resistant prostate cancer and to determine the most appropriate dose of this combination. In the Phase I part of this study small groups of patients will be treated with increasing doses of tildrakizumab in combination with a fixed dose of abiraterone acetate (500mg once daily). Once Phase I has been completed the combination with the optimum safety and pharmacokinetic/pharmacodynamic profile will be taken forward to the Phase II part of the study. The Phase II part of the study will evaluate the optimized dose/schedule identified in Phase I of the study in patients with metastatic castration resistant prostate cancer.
Timeline
- Start
- 2020-12-01
- Primary completion
- 2023-04-01
- Completion
- 2023-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tildrakizumab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Tildrakizumab | Monoclonal antibody | 300 mg | Intravenous |
| Subject | Tildrakizumab | Monoclonal antibody | 600 mg | Intravenous |
| Background | Abiraterone acetate | Small molecule | 500 mg | Oral |