Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorSURGE Therapeutics
About this trial
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males aged 18 years or older at time of informed consent.
Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
Grade Group 2-5.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
Disqualifiers
Have an invasive malignancy, other than the disease under study.
Anticipated to require the use of a drain after radical prostatectomy.
Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy ) within 28 days.
History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including poloxamer 407 and sodium hyaluronate.
Trial design
Design model
Single group
Treatments tested in this trial
STM-416p
DrugSTM-416p monotherapy
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: STM-416pExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence 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 Days2
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 daysSecondary outcomes
1
Pharmacokinetics of STM-416p
Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood
Time frame
Day 0, post 24 hours, post 48 hour2
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 days3
Assess surgical wound healing
Assessment of wound healing scored according to a modified ASEPSIS method
Time frame
Day 7, Day 21Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov