Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
Conditions
Prostate CancerDrugs
STM-416pSummary
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
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Danielle Geckler
Eligibility Criteria
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.
Study Plan
STM-416p
EXPERIMENTAL
STM-416p
DRUG:
STM-416pDescription:
STM-416p monotherapy
Outcome Measures
Primary Outcome Measures
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary Outcome Measures
Pharmacokinetics of STM-416p
Pharmacodynamics of STM-416p in blood circulating cytokines
Assess surgical wound healing
Timeline
Last Updated
June 27, 2025Start Date
June 10, 2024Today
October 16, 2025Completion Date ( Estimated )
March 1, 2026
Sponsors of this trial
Lead Sponsor
SURGE Therapeutics