A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy
M.D. Anderson Cancer Center
Summary
To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.
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 cance…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Men ≥ 18 years of age * Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of Gleason 8 or greater. Prostate biopsy within 3 months of screening is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas or mixed histologies are not eligible * Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1 * No evidence of metastatic disease as docum…
Interventions
- DrugREGN5678
Given by IV (vein)
- DrugPiflufolastat F18
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas