A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
STM-416p monotherapy
Arizona Urology Specialists
Tucson, Arizona, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGAustralian Prostate Center
Melbourne N., Victoria, Australia
RECRUITINGIncidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment
Time frame: 21 Days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Time on trial up to 90 days
Pharmacokinetics of STM-416p
Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood
Time frame: Day 0, post 24 hours, post 48 hour
Pharmacodynamics of STM-416p in blood circulating cytokines
Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level
Time frame: Day 0, post 24 hours, post 48 hours, post 21 days
Assess surgical wound healing
Assessment of wound healing scored according to a modified ASEPSIS method
Time frame: Day 7, Day 21
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Epworth HealthCare
Melbourne N., Victoria, Australia
RECRUITING