AzTrials
AzTrials

Non-muscle-invasive Bladder CancerPhase 1/2NCT05710848

A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer

A Phase 1/2 study testing STM-416 in people with Non-muscle-invasive Bladder Cancer, run by SURGE Therapeutics at 20 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-muscle-invasive Bladder Cancer
What is being tested?
STM-416
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
20 sitesUnited States
Study dates
11 Jul 2023to Aug 2026
Phase
Phase 1/2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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 join

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

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kayti Aviano contact

781-605-8632

kayti@surgetx.com

20 sites in 1 country

United States20 sites, 19 recruiting

  • Anna Arundel Urology

    Annapolis, Maryland, 21410

    Megan Lormore

    Mara Holton, MD

    Recruiting

  • Unio Specialty Care - A Genesis Healthcare Partners Facility

    Bakersfield, California, 93301

    Evelyn De La Cruz

    Michael Oefelein, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Nnamdi Onochie, nnamdi_onochie@dfci.harvard.edu

    Matthew Mossanen, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43221

    Audrey Knight, Audrey.Knight@osumc.edu

    Debasish Sundi, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Corey Nixon, corey.nixon@UTsouthwestern.eduUTsouthwestern.eduTSouthwestern.edu

    Yair Lotan, MD

    Recruiting

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114

    Sara Esposito

    Samuel Lawindy, MD

    Recruiting

  • Genesis Research

    Downey, California, 90241

    Michelle Martinez

    Sepehr Nowfar, MD

    Recruiting

  • Urology Partners of North Texas

    Fort Worth, Texas, 76132

    Grace Yoon

    Adam Hollander, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32608

    Tian White, tian.white@ufl.edu

    Padraic O'Malley, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Rosalind Mouton, Rosalind.Mouton@bcm.edu

    Seth Paul Lerner, MD

    Recruiting

  • Houston Methodist

    Houston, Texas, 77030

    Karina Lozano, kplozano@houstonmethodist.org

    Dharam Kaushik, MD

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansas, 72211

    Katie O'Brien

    Jonathan Henderson, MD

    Recruiting

  • East Valley Urology Center of Arizona

    Mesa, Arizona, 85206

    Alekhya Padavala

    Harpreet Wadhwa

    Recruiting

  • Urology Center of Southern California

    Murrieta, California, 28078

    Laura Guerrero

    Madhumitha Reddy, MD

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Rikki Waldorf, rwaldorf@curcmb.com

    Abhishek Srivastava, MD

    Recruiting

  • Lowcountry Urology

    North Charleston, South Carolina, 29406

    Madalyn Colbert

    Justin Ellett, MD

    Recruiting

  • Advent Health

    Orlando, Florida, 32803

    Genevieve Rexford, genevieve.rexford@adventhealth.com

    Zachary Smith, MD

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Hannah Landry, landryh@uthscsa.edu

    Ahmed Mansour, MD

    Recruiting

  • Michigan Institute of Urology

    Troy, Michigan, 48084

    Danielle Osterhout

    Jason Hafron, MD

    Recruiting

  • Arizona Urology Specialists

    Tucson, Arizona, 85715

    Completed

Other trials in United States

About this study

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

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.

Read the detailed description

This is a 2-part, multicenter, first-in-human (FIH), Phase 1/2a study in patients with 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. All patients will receive relevant SOC therapy following TURBT. SOC will be administered in the adjuvant setting.

Phase 1 is an open-label, single-treatment, dose-escalation study to evaluate the safety and tolerability of up to 6 increasing doses of intraoperatively administered STM-416 utilizing a 3+3 convention, with 3 to 6 patients enrolled in each STM-416 dose level, with a minimum of 6 patients enrolled at the highest dose level, for a total of approximately 30 patients.

Phase 2a is a randomized, single-blind, single-treatment, dose-expansion study that will comprise 2 arms: TURBT + STM-416 Dose 1 followed by SOC versus TURBT + STM-416 Dose 2 followed by SOC.

Being tested
STM-416
Keywords
Open-label, Dose escalation, STM-416, Resiquimod, Toll-like receptor 7/8, Non-Muscle Invasive Bladder Cancer, TURBT, Immunotherapy, BCG
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STM-416Drug

    STM-416 monotherapy

Study groups in NCT05710848
Study groupRoleWhat they receive
STM-416ExperimentalSTM-416
Receives: Drug: STM-416

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1

    Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment

    Measured: 21 days

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1

    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

  3. Recurrence free survival time (Phase 2a)

    Recurrence will be evaluated by cystoscopy and urine cytology

    Measured: Through study completion up to 24 months

Secondary outcomes (3)

  1. Pharmacokinetics of STM-416 (Phase 1)

    Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood for the single dose level (Phase 1)

    Measured: Day 0, post 24 hours, post 48 hour

  2. Pharmacokinetics of STM-416 (Phase 1)

    Area under the plasma concentration versus time curve (AUC) of resiquimod (R848) in patient blood for the single dose level (Phase 1)

    Measured: Day 0, post 24 hours, post 24 hour

  3. Pharmacodynamics of STM-416

    Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level for Phase 1/2a

    Measured: Day 0, post 24 hours, post 48 hours, post 21 days, post 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start11 Jul 2023
  3. Primary completionMay 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Singe group assignment
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05710848
Sponsor's protocol ID
STM-416-01
Status last verified
May 2026
First submitted
15 Dec 2022
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing STM-416 in people with Non-muscle-invasive Bladder Cancer, run by SURGE Therapeutics at 20 sites in United States.

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 11 inclusion and 6 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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] Phase 1 (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05710848.

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 27 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in