OncoMatch/Clinical Trials/NCT05710848
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
Is NCT05710848 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies STM-416 for non-muscle-invasive bladder cancer.
Treatment: STM-416 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Urothelial Carcinoma
Disease stage
Excluded: Stage CIS
Grade: high-grade
high-grade Ta or T1 NMIBC without CIS
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard of care
have completed SOC previously
Cannot have received: perioperative intravesical chemotherapy
undergoing TURBT without perioperative intravesical chemotherapy
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 75 × 10^9/L
Kidney function
Creatinine CL ≥ 60 mL/min by Cockcroft-Gault or 24-hour urine collection
Liver function
Serum bilirubin ≤ 1.5 × institutional ULN; AST/ALT ≤ 2.5 × institutional ULN
Have adequate organ and marrow function as defined below: * Hemoglobin 9.0 g/dL; * Absolute neutrophil count 1.5 × 10^9/L (1500 per mm3); * Platelet count 75 × 10^9/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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Urology Specialists · Tucson, Arizona
- University of Florida · Gainesville, Florida
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Duke Cancer Center · Durham, North Carolina
- The Ohio State University · Columbus, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05710848 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior perioperative intravesical chemotherapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages