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STM-416 for Recurrent Non-muscle-invasive Bladder Cancer

This study is testing a new treatment called STM-416 for people with non-muscle-invasive bladder cancer (NMIBC) that has come back. You might be able to join if you are 18 or older, have high-grade NMIBC without CIS (carcinoma in situ) that has recurred, and are having a TURBT (Transurethral Resection of Bladder Tumor) procedure. The main goals are to see how safe STM-416 is and what side effects it might cause. Researchers also want to see how long people stay cancer-free after treatment. This study is currently enrolling about 75 participants.

Study design
This is a Phase 1/2a, multi-center, open-label study with two parts: a dose-escalation phase (Phase 1) and a dose-expansion phase (Phase 2a). Phase 1 will involve 30 patients, and Phase 2a will be randomized and single-blind.
What's involved
You will receive STM-416 during your TURBT procedure. You will be followed for safety for up to 90 days and for recurrence-free survival for up to 24 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed through study completion, which can be up to 24 months, to track recurrence-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05710848

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
SURGE Therapeutics
~75 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:STM-416

At a glance

Recruiting sites
19 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1
Measured over 21 days
+2 more outcomes measured

Conditions

Non-muscle-invasive Bladder Cancer

Explore related trials

Non-Muscle Invasive Bladder Carcinoma

NCT05710848

Where you'd take part

This study runs at 20 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advent Health

    Orlando, Floridastudy coordinator listed

    Recruiting

  • Baylor College of Medicine

    Houston, Texasstudy coordinator listed

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolinastudy coordinator listed

    Recruiting

  • Houston Methodist

    Houston, Texasstudy coordinator listed

    Recruiting

  • The Ohio State University

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • University of Florida

    Gainesville, Floridastudy coordinator listed

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Seth Lerner, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Kayti Aviano
[email protected]
781-605-8632
Email the study team

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Eligibility criteria

Inclusion

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).

What this trial measures

  • Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 121 days

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

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1Time 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

  • Recurrence free survival time (Phase 2a)Through study completion up to 24 months

    Recurrence will be evaluated by cystoscopy and urine cytology