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

Clinicaltrials.gov ID: NCT06450106
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 18

Conditions

Prostate Cancer

Drugs

STM-416p

Summary

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

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-416p

    Description:

    STM-416p monotherapy

Outcome Measures

Primary Outcome Measures

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

Time Frame: 21 Days

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

Time Frame: Time on trial up to 90 days

Secondary Outcome Measures

Pharmacokinetics of STM-416p

Time Frame: Day 0, post 24 hours, post 48 hour

Pharmacodynamics of STM-416p in blood circulating cytokines

Time Frame: Day 0, post 24 hours, post 48 hours, post 21 days

Assess surgical wound healing

Time Frame: Day 7, Day 21

Timeline

  • Last Updated
    June 27, 2025
  • Start Date
    June 10, 2024
  • Today
    October 16, 2025
  • Completion Date ( Estimated )
    March 1, 2026

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