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

NCT06450106 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STM-416p-201
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Intraoperative; Dose escalation; Open-label; STM-416; Resiquimod; Toll-like receptor 7/8; Radical prostatectomy; Robotic prostatectomy; Immunotherapy; STM-416p; PSA; R848; Hydrogel

Outcome Measures

Primary Outcomes (2)

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

  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]

  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 Outcomes (3)

• Pharmacokinetics of STM-416p

  Day 0, post 24 hours, post 48 hour

• Pharmacodynamics of STM-416p in blood circulating cytokines

  Day 0, post 24 hours, post 48 hours, post 21 days

• Assess surgical wound healing

  Day 7, Day 21

Study Arms (1)

STM-416p

EXPERIMENTAL

STM-416p

Drug: STM-416p

Interventions

STM-416p DRUG

STM-416p monotherapy

STM-416p

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SURGE Therapeutics: lead

Study Sites (4)

Arizona Urology Specialists

Tucson, Arizona, 85715, United States

RECRUITING

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Australian Prostate Center

Melbourne N., Victoria, 3051, Australia

RECRUITING

Epworth HealthCare

Melbourne N., Victoria, 3051, Australia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Kayti Aviano

CONTACT

781-605-8632; kayti@surgetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 10, 2024
• Study Start: May 8, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); AU (2)