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 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

Trial Details

NCT ID
NCT04752722
Phase
PHASE1 / PHASE2
Sponsor
enGene, Inc.
Status
RECRUITING
Cancer Type
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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