EG-70 in NMIBC Patients Who Are BCG-Unresponsive and High-Risk NMIBC Patients Who Have Been Incompletely Treated With BCG or Are BCG-Naïve (LEGEND STUDY)
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|ClinicalTrials.gov Identifier: NCT04752722|
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : November 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Superficial Bladder Cancer||Drug: EG-70||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||222 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients With BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment|
|Actual Study Start Date :||April 22, 2021|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||February 2026|
Experimental: Phase 1
Dose escalation phase
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.
Other Name: Phase 1
Experimental: Phase 2
Cohort 1: Recommended Phase 2 dose (RP2D) with eligible BCG-unresponsive NMIBC patients, up to 4 cycles of treatment with EG-70
Cohort 2: RP2D with eligible high-risk NMIBC patients who have been incompletely treated with BCG or are BCG-naïve
Cohort 1 and Cohort 2: Patients will receive 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).
Other Name: Phase 2
- Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0. [ Time Frame: Approximately 2 years ]The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.
- Phase 2: Percentage of patients with cystoscopic CR at 48 weeks, based on exam, urine cytology and appropriate biopsies. [ Time Frame: Approximately 48 weeks ]Complete response rate will be measured by determining the number of patients without recurrence of high-grade disease.
- Phase 2: Nature, incidence, relatedness, and severity of treatment emergent adverse events (as assessed by CTCAE v5.0) [ Time Frame: Approximately 3 years ]The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.
- Phase 1: The number of patients who experience a DLT through the end of Cycle 1 [ Time Frame: Approximately 1 year ]To identify the number of patients who experience a DLT through the end of Cycle 1
- Phase 1: CR rate to EG-70 by cystoscopy at approximately 12 weeks. [ Time Frame: Approximately 12 weeks ]To evaluate preliminary efficacy of EG-70 by 12 weeks via cystoscopy
- Phase 2: Progression-free survival (PFS) [ Time Frame: Approximately 4 years ]To evaluate disease-free survival rate.
- Phase 2: CR rate at 12, 24, 36, and 96 weeks [ Time Frame: Approximately 12, 24, 36, and 96 weeks ]To further evaluate CR at the efficacy analysis following each cycle.
- Phase 2: Duration of response of the responding patients [ Time Frame: Approximately 3 years ]Durability will be measured by determining the number of patients without recurrence of high-grade disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752722
|Contact: Bao Lefirstname.lastname@example.org|
|Contact: Loraine Warneremail@example.com|
|United States, Arizona|
|Urological Associates of South Arizona, PLLC||Recruiting|
|Tucson, Arizona, United States, 85715|
|United States, California|
|Urology Group of Southern California||Recruiting|
|Los Angeles, California, United States, 90017|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|United States, New Jersey|
|New Jersey Urology, LLC||Recruiting|
|Voorhees, New Jersey, United States, 08043|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|