A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

STM-416p-201

A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

2024-09-01

2025-12-01

2026-03-01

Not yet recruiting

Early phase I

18

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}

2024-06-10