drugset / Trial / NCT02693860

Neoadjuvant J591 Treatment for Prostate Cancer

NCT02693860 ↗

Phase 1 Completed 8 enrolled Weill Medical College of Cornell University
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

EvaluationDrugModalityDoseRoute
Subject 89Zr-J591 Unknown — —
Subject huJ591 Monoclonal antibody 100 mg Intravenous

Indications