LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve

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.

Trial Details

NCT ID
NCT04752722
Phase
PHASE1 / PHASE2
Sponsor
enGene, Inc.
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • EG-70 (phase 1)
  • EG-70 (phase 2)
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Irvine, California, United States|33.66946,-117.82311

Key Eligibility Criteria

  • BCG-unresponsive Patients:
  • BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without coexisting papillary Ta/T1 tumors who are ineligible for or have elected not to…
  • Phase 2 Only:
  • BCG-Naïve or BCG-incompletely treated Patients with CIS or BCG-unresponsive, HG Ta/T1 papillary disease without CIS:

For full eligibility, visit ClinicalTrials.gov.

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