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Clinical Trial Summary

To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.


Clinical Trial Description

Primary Objectives: • To evaluate safety and tolerability of REGN5678 (antiPSMAxCD28) in patients with high-risk, localized prostate cancer. Secondary Objectives: • To assess the proportion of patients who achieve pathological response with REGN5678 in men with high-risk, localized prostate cancer. Exploratory Objectives: - To evaluate immune responses in the prostate tumor microenvironment and peripheral blood after treatment with REGN5678 as compared to pre-treatment samples and untreated control samples. - To evaluate efficacy of REGN5678 in men with high-risk, localized prostate cancer. To evaluate exploratory imaging biomarkers for REGN5678 by PSMA PET/CT and FDG PET/CT ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06085664
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Sumit Subudhi, MD, PHD
Phone (713) 792-2830
Email sksubudhi@mdanderson.org
Status Recruiting
Phase Phase 1/Phase 2
Start date December 4, 2023
Completion date June 15, 2026

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