Prostate CancerPhase 1NCT06450106
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
A Phase 1 study testing STM-416p in people with Prostate Cancer, run by SURGE Therapeutics at 4 sites in 2 countries.
Trial summary
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- STM-416p
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 May 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Danielle Geckler
d.geckler@ufl.edu
- Recruiting
Arizona Urology Specialists
Tucson, Arizona, 85715
Jasmine Simpson, JSIMPSON@arizonauro.com
Susan Kalota, MD
Australia2 sites, 2 recruiting
- Recruiting
Australian Prostate Center
Melbourne N., Victoria, 3051
Dina Bushell, dina.bushell@apcr.org.au
Phil Dundee, MD
- Recruiting
Epworth HealthCare
Melbourne N., Victoria, 3051
Daniel Shokouhi, ctc-urorenal@epworth.org.au
Nathan Lawrentschuk, Prof
About this study
Official title: 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
Read the detailed description
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
- Conditions
- Prostate Cancer
- Being tested
- STM-416p
- Keywords
- Intraoperative, Dose escalation, Open-label, STM-416, Resiquimod, Toll-like receptor 7/8, Radical prostatectomy, Robotic prostatectomy, Immunotherapy, STM-416p, PSA, R848, Hydrogel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STM-416pDrug
STM-416p monotherapy
| Study group | Role | What they receive |
|---|---|---|
| STM-416p | Experimental | STM-416p Receives: Drug: STM-416p |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment
Measured: 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
Measured: Time on trial up to 90 days
Secondary outcomes (3)
Pharmacokinetics of STM-416p
Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood
Measured: Day 0, post 24 hours, post 48 hour
Pharmacodynamics of STM-416p in blood circulating cytokines
Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level
Measured: Day 0, post 24 hours, post 48 hours, post 21 days
Assess surgical wound healing
Assessment of wound healing scored according to a modified ASEPSIS method
Measured: Day 7, Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start8 May 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SURGE Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450106
- Sponsor's protocol ID
- STM-416p-201
- Status last verified
- Feb 2026
- First submitted
- 2 Jun 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06450106
- Acronym / sponsor ID
- STM-416p-201
- Conditions
- Prostate Cancer
- Keywords
- Intraoperative, Dose escalation, Open-label, STM-416, Resiquimod, Toll-like receptor 7/8, Radical prostatectomy, Robotic prostatectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- SURGE TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 May 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| STM-416p | Experimental | Drug: STM-416pSTM-416p |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STM-416pSTM-416p monotherapy | Drug | STM-416p |
Primary outcome
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
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STM-416p in people with Prostate Cancer, run by SURGE Therapeutics at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayti Aviano (781-605-8632, kayti@surgetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] (time frame: 21 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.