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Pilot Study Evaluating REGN5678 Given Before Surgery for Men With High-Risk Localized Prostate Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-07-02
42
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a drug called REGN5678 in men with high-risk, localized prostate cancer. The study aims to understand how well REGN5678 is tolerated and its impact on the disease before surgery. It also explores immune responses in the tumor and blood and uses advanced imaging techniques to assess the drugs effects. Participants will receive REGN5678 through an intravenous infusion, starting with a 2-hour dose followed by weekly doses for six weeks. Initial dosing occurs while admitted to the hospital for close monitoring, with subsequent doses given over 30 to 90 minutes depending on tolerance. The study includes assessments before and after treatment to evaluate response. During the trial, participants will undergo regular clinical visits for treatment and monitoring. Researchers will track side effects using standardized criteria and measure immune responses and imaging biomarkers. Participation involves complying with clinic visits and procedures, and safety is monitored throughout the study, which continues up to one year after treatment completion.
CONDITIONS
Brief Title
A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy
Research Team
S
Sumit Subudhi, MD, PHD
S
Sumit Sumit, MD, PHD
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