drugset / Trial / NCT02693860
Neoadjuvant J591 Treatment for Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
10 patients will be enrolled in the initial cohort and will receive two infusions of unlabeled huJ591 on days 1 and 14. 89Zr-J591 will be administered on day 21 (+ 1 day) and a positron emission tomography-computed tomography (PET/CT) will be performed week later on day 28 + 1 (visit 4). Approximately 2 to 3 weeks after the 2nd dose of J591, the patient will undergo radical prostatectomy with or without lymph node dissection (day 31 + 4 days). The final visit for the study will include a postoperative visit two weeks following surgery.
Timeline
- Start
- 2016-02-04
- Primary completion
- 2017-02-10
- Completion
- 2020-02-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 89Zr-J591 | Unknown | — | — |
| Subject | huJ591 | Monoclonal antibody | 100 mg | Intravenous |