Radioimmunotherapy (RIT) Dose-Escalation Studies in Prostate Cancer Using Anti-PSMA Antibody 177Lu-J591: RIT Alone and RIT in Combination with Docetaxel
Abstract
Phase I dose escalation studies with 177Lu-DOTA-huJ591 using dose fractionation regimen will be performed in patients with PCa and who have recurrent and/or metastatic disease. The 177Lu dose (20-45 mCi/m2) will be escalated in 6 different dose levels (3-6 patients at each dose level). At each dose level, the patients would receive two doses of 177Lu-J591 Mab, 2 weeks apart. The dose of huJ591 MAb will remain fixed at a total dose of 20 mg/dose. After almost 2.5 years of discussions, the phase I protocol was finally approved in Aug 2007 by HSSRB at DOD. In January 2007, we prepared a new lot of DOTAJ591 under GMP conditions for clinical studies. After receiving the approval, we started clinical studies in August 2007. We already recruited the first 3 subjects in Group-1. We hope to complete the first trial by June 2008 and start the combination therapy protocol almost immediately. We plan to complete the study in march 2009. The revised SOW is attached.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2007
- Accession Number
- ADA477274
Entities
People
- Shankar Vallabhajosula
Organizations
- Cornell University