Recruiting
Phase 1

STM-416p

Sponsor:

SURGE Therapeutics

Code:

NCT06450106

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STM-416p

Study Details

Brief summary:

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

Conditions

Prostate Cancer

Study ID

NCT06450106

Start date

May 8, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: STM-416p

STM-416p

Interventions

STM-416p

STM-416p monotherapy

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Arizona Urology Specialists

Recruiting

Tucson, Arizona, United States, 85715

Contacts

Principal Investigator:

Susan Kalota, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Principal Investigator:

Paul Crispen, MD

More Information

Sponsor

SURGE Therapeutics

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SURGE Therapeutics on 2026-02-19.