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New bladder cancer gel shows promise in early trial

NCT ID NCT05710848

Disease control Sponsor: SURGE Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called STM-416 that is applied directly to the bladder during surgery to remove tumors. It is for people with a type of bladder cancer that keeps coming back. The goal is to see if the drug is safe and can help keep the cancer from returning. About 75 adults with recurrent high-grade bladder cancer will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Are aged 18 years or older; 2. Have a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously, with recurrent papillary disease seen on cystoscopy, and who are undergoing TURBT without perioperative intravesical chemotherapy; 3. Are considered high risk for recurrence; 4. Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2; 5. Have adequate organ and marrow function as defined below: * Hemoglobin 9.0 g/dL; * Absolute neutrophil count 1.5 × 109/L (1500 per mm3); * Platelet count 75 × 109/L (75,000 per mm3); * Serum bilirubin 1.5 × institutional upper limit of normal (ULN); * AST (serum glutamic-oxaloacetic transaminase)/ALT (serum glutamic-pyruvic transaminase) 2.5 × institutional ULN; and * Creatinine CL 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL: Males: Creatinine CL (mL/min) = Weight (kg) × (140 - Age)/72 × serum creatinine (mg/dL); or Females: Creatinine CL (mL/min) = Weight (kg) × (140 - Age) × 0.85/72 × serum creatinine (mg/dL). Exclusion Criteria: 1. Have a history of CIS or MIBC; 2. Are receiving any other investigational agents; 3. Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to resiquimod (R848), or excipients used in STM-416 including poloxamer 407 and sodium hyaluronate; 4. Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher; 5. Are a woman of childbearing potential regardless of contraceptive use; Note: Women of childbearing potential are only to be excluded in Phase 1 and Phase 2a to avoid bias due to the low prevalence of NMIBC in this population. However, they will be included in subsequent Phase 2/3 studies.

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Conditions

The condition(s) this trial relates to.

bladder papillary urothelial carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-muscle invasive bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Urology Institute

    RECRUITING

    Daytona Beach, Florida, 32114, United States

  • Advent Health

    RECRUITING

    Orlando, Florida, 32803, United States

  • Anna Arundel Urology

    RECRUITING

    Annapolis, Maryland, 21410, United States

  • Arizona Urology Specialists

    COMPLETED

    Tucson, Arizona, 85715, United States

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • East Valley Urology Center of Arizona

    RECRUITING

    Mesa, Arizona, 85206, United States

  • Genesis Research

    RECRUITING

    Downey, California, 90241, United States

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • Lowcountry Urology

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Michigan Institute of Urology

    RECRUITING

    Troy, Michigan, 48084, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43221, United States

  • Unio Specialty Care - A Genesis Healthcare Partners Facility

    RECRUITING

    Bakersfield, California, 93301, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Urology Center of Southern California

    RECRUITING

    Murrieta, California, 28078, United States

  • Urology Partners of North Texas

    RECRUITING

    Fort Worth, Texas, 76132, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.