RecruitingPhase 1NCT06450106

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

Sponsor

SURGE Therapeutics

Enrollment

18 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

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

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.