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 (May 2026). This Phase 1/2 trial studies multiple treatments including EG-70 (phase 1) and EG-70 (phase 2) for superficial bladder cancer.
Treatment: EG-70 (phase 1) · EG-70 (phase 2) — This study will evaluate the safety and efficacy of intravesical administration of 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 patients with NMIBC with Cis who are BCG-naïve or inadequately treated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CIS (bladder TNM)
Excluded: Stage MUSCLE INVASIVE, IV
Grade: high-grade
BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without coexisting papillary Ta/T1 tumors
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCG — BCG-unresponsive cohort: at least 2 courses (induction: ≥5 or 6 doses; second course: re-induction or maintenance ≥2 doses)
adequate BCG regimen consists of at least 2 courses of BCG where the first course (induction) must have included at least 5 or 6 doses and the second course may have included a re-induction (at least 2 treatments) or maintenance (at least 2 doses)
Cannot have received: chemotherapy
Concurrent treatment with any chemotherapeutic agent
Cannot have received: systemic immunosuppressive medication (high-dose corticosteroids)
Patients who have received systemic immunosuppressive medication including high-dose corticosteroids
Cannot have received: investigational gene or immunotherapy agent
any prior treatment of NMIBC with any investigational gene or immunotherapy agent
Cannot have received: external beam radiation
History of external beam radiation to the pelvis or prostate brachytherapy within the last 12 months
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 ≤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 →
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