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OncoMatch/Clinical Trials/NCT05710848

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

Is NCT05710848 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies STM-416 for non-muscle-invasive bladder cancer.

Phase 1/2RecruitingSURGE TherapeuticsNCT05710848Data as of May 2026

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.

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Extracted eligibility criteria

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 →

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