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Taking people in United StatesPhase 1/2

Tests STM-416 during bladder tumor removal surgery for recurrent bladder cancer

Tests STM-416 safety in adults with recurrent high-grade bladder cancer.

Key facts

Who runs it
SURGE Therapeutics
Where
Annapolis, Bakersfield, Boston, Columbus, Dallas, Daytona Beach, Downey, Fort Worth, Gainesville, Houston, Little Rock, Mesa, Murrieta, Myrtle Beach, North Charleston, Orlando, San Antonio, Troy, and Tucson, United StatesSee the 20 sites
Trial code
Registry title
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
Status
Recruiting
Phase
Phase 1/2
People taking part
75 people, planned
Started
11 Jul 2023
Planned end
Aug 2026
Type of study
Interventional
Treatments tested
  • STM-416
Record updated
27 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with recurrent high-grade papillary non-muscle-invasive bladder cancer who are having a bladder tumor removal operation (TURBT).

Age
18 years or older
Sex
All sexes, but women who could become pregnant cannot join in Phase 1 and Phase 2a.
Disease stage
High-grade Ta or T1 non-muscle-invasive bladder cancer without CIS, with papillary disease that has come back. Considered high risk for recurrence. ECOG performance status 0, 1 or 2.
Earlier treatment
Must have finished standard of care before. Must be having TURBT without intravesical chemotherapy during the operation.

Main reasons for not taking part

  • History of CIS or MIBC
  • Taking any other investigational agent
  • Allergy to resiquimod (R848), poloxamer 407 or sodium hyaluronate
  • Uncontrolled illness, such as active infection or heart failure
  • Woman who could become pregnant (Phase 1 and Phase 2a)

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Are aged 18 years or older
  • 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
  • Are considered high risk for recurrence
  • Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • 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)

Who cannot take part

  • Are receiving any other investigational agents
  • Have a history of CIS or MIBC
  • 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
  • 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
  • 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

Where in United States

  • Anna Arundel UrologyAnnapolis, United StatesContact: Megan LormoreTaking people
  • Unio Specialty Care - A Genesis Healthcare Partners FacilityBakersfield, United StatesContact: Evelyn De La CruzTaking people
  • Brigham and Women's HospitalBoston, United StatesContact: Nnamdi OnochieTaking people
  • The Ohio State UniversityColumbus, United StatesContact: Audrey KnightTaking people
  • University of Texas Southwestern Medical CenterDallas, United StatesContact: Corey NixonTaking people
  • Advanced Urology InstituteDaytona Beach, United StatesContact: Sara EspositoTaking people
  • Genesis ResearchDowney, United StatesContact: Michelle MartinezTaking people
  • Urology Partners of North TexasFort Worth, United StatesContact: Grace YoonTaking people
  • University of FloridaGainesville, United StatesContact: Tian WhiteTaking people
  • Baylor College of MedicineHouston, United StatesContact: Rosalind MoutonTaking people
  • Houston MethodistHouston, United StatesContact: Karina LozanoTaking people
  • Arkansas UrologyLittle Rock, United StatesContact: Katie O'BrienTaking people
  • East Valley Urology Center of ArizonaMesa, United StatesContact: Alekhya PadavalaTaking people
  • Urology Center of Southern CaliforniaMurrieta, United StatesContact: Laura GuerreroTaking people
  • Carolina Urologic Research CenterMyrtle Beach, United StatesContact: Rikki WaldorfTaking people
  • Lowcountry UrologyNorth Charleston, United StatesContact: Madalyn ColbertTaking people
  • Advent HealthOrlando, United StatesContact: Genevieve RexfordTaking people
  • University of Texas Health Science Center at San AntonioSan Antonio, United StatesContact: Hannah LandryTaking people
  • Michigan Institute of UrologyTroy, United StatesContact: Danielle OsterhoutTaking people
  • Arizona Urology SpecialistsTucson, United StatesContact: Kayti AvianoNo longer taking part

About the trial

What the trial wants to find out

This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.

The group in the trial

  • STM-416Treatment being tested

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer
Plain-language title
Tests STM-416 during bladder tumor removal surgery for recurrent bladder cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 May 2026