A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG -Unresponsive NMIBC and High-Risk NMIBC Patients who are BCG Naïve or Received Incomplete BCG Treatment

Phase 1: The purpose of this study is to evaluate the safety and tolerability of escalating dose levels of EG-70 administered by intravesical instillation in patients with BCG-unresponsive NMIBC who are scheduled for, refuse, or are ineligible for radical cystectomy

Phase 2: the purpose of this study is to evaluate the efficacy of EG-70 (determined by complete response) at 48 weeks in each cohort separately. To evaluate the safety of the RP2D of EG-70 administered by intravesical instillation in patients with BCG-unresponsive NMIBC and patients with high-risk NMIBC who are BCG naïve or have received incomplete BCG treatment

Inclusion Criteria: 

BCG-Unresponsive Patients (Phase 1 and Phase 2-Cohort 1):

1) BCG Unresponsive NMIBC with CIS of the bladder who are ineligible for or have elected not to undergo cystectomy, and have experienced a) persistent disease within 12 months of treatment or b) a recurrence within 6 months of completion of adequate BCG therapy

BCG-Naive or BCG-incompletely Treated Patients (Phase 2-Cohort 2 only):

2) NMIBC with current CIS of the bladder, who are ineligible for or have elected not to undergo cystectomy where either a) incomplete BCG (at least 1 dose) treatment or b) no treatment with BCG but who have previously been treated with at least 1 dose of intravesical chemotherapy following transurethral resection of bladder tumor (TURBT) and CIS must be documented or indicated by pathology within 4 months of or at screening

3) Aged 18 years of age or older

4) Performance Status: ECOG 0-2

Exclusion Criteria: 

1) Concurrent treatment with any chemotherapeutic agent

2) Evidence of persistent or ongoing renal failure

3) Evidence of metastatic disease