Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
Recruiting · NCT06450106 · Interventional (participants receive a specific treatment) · Lead sponsor: SURGE Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
STM-416p
What this trial is about
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Have adequate organ and bone marrow function at screening.
- Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document
Exclusion criteria
- 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.
- History of allogeneic organ transplant.
- History of primary immunodeficiency.
- QTc interval \>470 msec at Screening.
Where it is running
4 locations listed across 2 US states.
- Arizona Urology Specialists - Tucson, Arizona, United States
- University of Florida - Gainesville, Florida, United States
- Australian Prostate Center - Melbourne N., Victoria, Australia
- Epworth HealthCare - Melbourne N., Victoria, Australia