OncoMatch/Clinical Trials/NCT04752722
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
Is NCT04752722 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including EG-70 (phase 1) and EG-70 (phase 2) Master Protocol for superficial bladder cancer.
Treatment: EG-70 (phase 1) · EG-70 (phase 2) Master Protocol · Surfactant Bladder Pre-Rinse and EG-70 (Substudy) — This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with: NMIBC with CIS for whom BCG therapy is unresponsive, and other high risk patients with NMIBC. A Substudy will include a surfactant bladder rinse prior to the instillation of detalimogene in patients with NMIBC with CIS for whom BCG therapy is unresponsive.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Urothelial Carcinoma
Disease stage
Grade: high-grade
high-grade NMIBC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic immunosuppressive medication (high-dose corticosteroids)
Patients who have received systemic immunosuppressive medication including high-dose corticosteroids
Lab requirements
Blood counts
Absolute neutrophil count >1,500/mm3; Hemoglobin >9.0 g/dL; Platelet count >100,000/mm3
Kidney function
creatinine clearance >30 mL/min
Liver function
Total bilirubin must be ≤1.5 x ULN; AST, ALT, and alkaline phosphatase ≤2.5 x ULN
Hematologic inclusion: a. Absolute neutrophil count >1,500/mm3. b. Hemoglobin >9.0 g/dL. c. Platelet count >100,000/mm3. Hepatic inclusion: a. Total bilirubin must be ≤1.5 x ULN. b. AST, ALT, and alkaline phosphatase ≤2.5 x ULN. Adequate renal function with creatinine clearance >30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Alabama at Birmingham Clinical Research Unit (CRU) · Birmingham, Alabama
- Mayo Clinic · Scottsdale, Arizona
- Urological Associates of South Arizona · Tucson, Arizona
- Arkansas Urology · Little Rock, Arkansas
- University of California - Irvine Medical Center · Irvine, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04752722 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic immunosuppressive medication 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