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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

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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