A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy
NCT06085664 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2026-05-05
Summary
To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.
Conditions
- Prostate Cancer
- Radical Prostatectomy
Interventions
- DRUG
-
REGN5678
Given by IV (vein)
- DRUG
-
Piflufolastat F18
Given by IV (vein)
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Sumit K Subudhi, MD, PHD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-04
- Primary Completion
- 2026-06-15
- Completion
- 2026-06-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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