NCT06085664

A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy

A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Prostate Cancer
• Radical Prostatectomy

Interventions

Type	Name	Description
DRUG	REGN5678	Given by IV (vein)
DRUG	Piflufolastat F18	Given by IV (vein)

Timeline

• Start date: 2023-12-04
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2023-10-17
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study