NCT05710848 · SURGE Therapeutics
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
What this study is about
This is a first-in-human (FIH), Phase 1/2a, multi center, where both patients and doctors know the treatment given, single treatment, gradually increasing doses and expansion study designed to determine the safety and how well patients handle the treatment of STM-416 in patients with bladder cancer.
View original scientific description
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.
Interventions
DRUG
STM-416
STM-416 monotherapy
Primary outcome measures
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1
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] Phase 1
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
Recurrence free survival time (Phase 2a)
Time frame: Through study completion up to 24 months
Recurrence will be evaluated by cystoscopy and urine cytology
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 - Ag
Where
- Mesa, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Bakersfield, California
- Downey, California
- Murrieta, California
- Daytona Beach, Florida
- Gainesville, Florida
- Orlando, Florida
- Annapolis, Maryland
- Boston, Massachusetts
- Troy, Michigan
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations