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

Conditions

• Non-muscle Invasive Bladder Cancer
• Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
• Superficial Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EG-70 (phase 1) — DRUG
  Patients will receive up to four cycles of EG-70 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes.One cycle lasts approximately 12 weeks and consists of either a 2-dose (Day 1 and Day 8) or 4-dose (Day 1, Day 8, Day 29 and Day 36) regimen.
• EG-70 (phase 2) Master Protocol — DRUG
  Under the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles, of EG-70 at the RP2D defined in Phase 1, administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes. One cycle lasts approximately 12 weeks. For Maintenance treatment 2 doses of EG-70 will be administered as a bladder instillation per 12-week cycle.
• Surfactant Bladder Pre-Rinse and EG-70 (Substudy) — DRUG
  Patients will receive via catheter a 50 mL volume of a 5-minute bladder rinse immediately prior to administration of 50 mL of detalimogene voraplasmid (EG-70) at the RP2D for 30 minutes. During the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles of the sudy intervention. One cycle lasts approximately 12 weeks. For Maintenance treatment, 2 doses of the study intervention will be administered as a bladder instillation per 12-week cycle.

Study Details

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.

Key Dates

First listed

Feb 12, 2021

Start date

Apr 22, 2021

Status verified

Aug 2026

Primary completion

Apr 30, 2028

Completion

Oct 30, 2030

Study Design

Enrollment

350 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1
  Dose escalation phase
• Experimental: Phase 2
  Cohort 1: Recommended Phase 2 dose (RP2D) with eligible BCG-unresponsive NMIBC patients with CIS, up to 4 cycles of treatment with EG-70. Patients in Complete Response continue to Maintenance Treatment. Cohorts 2A, 2B and 3: RP2D with eligible high-risk NMIBC patients with CIS who are BCG-naïve, BCG-exposed (incompletely treated with BCG) or BCG-unresponsive HG Ta/T1 papillary disease without CIS
• Experimental: Phase 1 Substudy Surfactant Bladder Rinse
  BCG-unresponsive NMIBC patients with CIS, up to 4 cycles of treatment with EG-70. Patients in Complete Response continue to Maintenance Treatment. Bladder Rinse Cohort: a 5-minute bladder rinse prior to administration of RP2D of detalimogene voraplasmid (EG-70) with a shortened administration time of 30 minutes.

Primary Outcome Measure

Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0. [ Time Frame: Approximately 2 years ]

Central Contacts

• enGene clinical trials
  +18572991097
  [email protected]
• Chris Tosone

Locations (50)

Find similar trials in Birmingham, AL

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