A Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Androgen-Independent Prostate Cancer
To determine the clinical activity of 177Lu -J591 for the treatment of patients with
metastatic, androgen-independent prostate cancer.
Patients will receive a single dose of J591 (total antibody of 20 mg) consisting of antibody
chelated with 177Lu at a dose of 65 or 70 mCi/m2 with a specific activity of 12-15 mCi/mg
plus non-radiolabeled antibody.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Define the PSA response rate.
PSA is measured at baseline, Day 1, 29, 43, 57 and 85, week 18 and 24, then every 12 weeks.
Scott Tagawa, M.D.
Weill Medical College of Cornell University
United States: Food and Drug Administration
|Weill Medcial College of Cornell University||New York, New York 10021|