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

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

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.