Study of AR Suppression With Carotuximab in Metastatic, Castration-Resistant Prostate Canc
Summary
This is an open-label, multi-site study of AR Blockade with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving AR Blockade and AR Blockade + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to AR blockade that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.
Timeline
- Start
- 2023-12-27
- Primary completion
- 2028-01
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apalutamide | Small molecule | 240 mg | Oral |
| Subject | Carotuximab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |