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

February 17, 2026 updated by: SURGE Therapeutics

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne N., Victoria, Australia, 3051
        • Recruiting
        • Australian Prostate Center
        • Contact:
        • Principal Investigator:
          • Phil Dundee, MD
      • Melbourne N., Victoria, Australia, 3051
        • Recruiting
        • Epworth Healthcare
        • Contact:
        • Principal Investigator:
          • Nathan Lawrentschuk, Prof
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Arizona Urology Specialists
        • Principal Investigator:
          • Susan Kalota, MD
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Paul Crispen, MD
        • Contact:
          • Danielle Geckler
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STM-416p
Drug: STM-416p
STM-416p monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Time Frame: 21 Days
Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment
21 Days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Time on trial up to 90 days
Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time on trial up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of STM-416p
Time Frame: Day 0, post 24 hours, post 48 hour
Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood
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
Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level
Day 0, post 24 hours, post 48 hours, post 21 days
Assess surgical wound healing
Time Frame: Day 7, Day 21
Assessment of wound healing scored according to a modified ASEPSIS method
Day 7, Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SURGE Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 2, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STM-416p-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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