NCT06450106PHASE1Recruiting
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
SURGE Therapeutics
Start Date
5/8/2025
Completion Date
12/1/2026
Summary
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Detailed Description
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. Males aged 18 years or older at time of informed consent.
2. Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
3. Grade Group 2-5.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
5. Have adequate organ and bone marrow function at screening.
6. Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document
Exclusion Criteria:
1. Have an invasive malignancy, other than the disease under study.
2. Anticipated to require the use of a drain after radical prostatectomy.
3. 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.
4. 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.
5. History of allogeneic organ transplant.
6. History of primary immunodeficiency.
7. QTc interval \>470 msec at Screening.
Interventions
DRUG
STM-416p
Conditions
Prostate Cancer
Locations
Arizona Urology Specialists
Tucson, Arizona 85715
United States
University of Florida
Gainesville, Florida 32608
United States
Australian Prostate Center
Melbourne N., Victoria 3051
Australia
Epworth HealthCare
Melbourne N., Victoria 3051
Australia