RecruitingPhase 1

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

United States, Australia18 participantsStarted 2025-05-08

Plain-language summary

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

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]

Timeframe: 21 Days

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: Time on trial up to 90 days

NCT IDNCT06450106

SponsorSURGE Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

Kayti Aviano

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.