Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
NCT ID: NCT06567743
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
325 participants
INTERVENTIONAL
2024-09-16
2027-12-30
Brief Summary
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Detailed Description
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In Cohort B, up to 150 participants will be enrolled with pathologically confirmed, high-risk high-grade NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which has previously been exposed to BCG treatment. Participants with CIS-containing pathology at baseline will be recruited into Arm 1 and participants with papillary-only pathology at baseline will be recruited into Arm 2. Both Cohort B Arms 1 and 2 will receive cretostimogene via the alternative instillation procedure.
In Cohort CX, up to 50 participants will be enrolled with pathologically confirmed, high-risk high-grade NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which has previously been exposed to or is unresponsive to BCG treatment. Participants will be randomized 1:1 to receive cretostimogene and gemcitabine either concurrently or sequentially.
In all cohorts, study treatment will be administered as a weekly induction course for the first 6 weeks with a reinduction course administered to patients who have CIS and/or high-grade Ta disease at the 3-month evaluation. Following induction, if no high-grade disease is detected, maintenance treatment will begin. This consists of a cycle of three weekly treatments every three months during the first year, and every six months during the second year, with an optional extension to the third year following the same six-month schedule.
Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), upper tract assessment and directed resection/biopsy (if indicated) every 3 months for the first 2 years and then every 6 months for a further 2 years or until disease recurrence.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: Cohort CX, Arm 1
At all treatment visits cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method followed by gemcitabine instilled intravesically
Cretostimogene Grenadenorepvec
Respective Cohort
Experimental: Cohort CX, Arm 2
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method for two consecutive weeks, followed by gemcitabine administered intravesically in the third week on a cyclic 2:1 visit schedule basis
Cretostimogene Grenadenorepvec
Respective Cohort
Experimental: Cohort B, Arm 2
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Cretostimogene Grenadenorepvec
Respective Cohort
Experimental: Cohort A, Arm 1
Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method
Cretostimogene Grenadenorepvec
Respective Cohort
Experimental: Cohort A, Arm 2
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Cretostimogene Grenadenorepvec
Respective Cohort
Experimental: Cohort A, Arm 3
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Cretostimogene Grenadenorepvec
Respective Cohort
Experimental: Cohort B, Arm 1
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Cretostimogene Grenadenorepvec
Respective Cohort
Interventions
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Cretostimogene Grenadenorepvec
Respective Cohort
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
* Acceptable baseline organ function.
* Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
* Acceptable baseline organ function.
* Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
* Acceptable baseline organ function.
Exclusion Criteria
* High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced/ nodal or metastatic disease in the upper urinary tract.
* Significant immunodeficiency.
* Pregnant or breastfeeding.
* Cohort CX Only: serial intravesical gemcitabine within 24 months
18 Years
ALL
No
Sponsors
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CG Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vijay Kasturi, MD
Role: STUDY_DIRECTOR
CG Oncology
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Arizona Urology Specialty
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Arkansas Urology
Little Rock, Arkansas, United States
Michael G Oefelein, MD Clinical Trials
Bakersfield, California, United States
Genesis Research (Greater Los Angeles)
Los Alamitos, California, United States
Advanced Urology
Los Angeles, California, United States
Urology Center of Southern California
Murrieta, California, United States
University of California, Irvine
Orange, California, United States
Om research
San Diego, California, United States
University of Southern California
San Diego, California, United States
Genesis Research (Greater Los Angeles)
Torrance, California, United States
Colorado Urology
Lakewood, Colorado, United States
Urology Associates, Lone Tree
Lone Tree, Colorado, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Advanced Urology Institute (Solaris)
Largo, Florida, United States
Advanced Urology Institute
Oxford, Florida, United States
Advanced Urology Institute - Tallahassee (Solaris)
Tallahassee, Florida, United States
Emory University
Atlanta, Georgia, United States
Associated Urological Specialists
Chicago Ridge, Illinois, United States
Uropartners
Glenview, Illinois, United States
Urology of Indiana - Carmel
Carmel, Indiana, United States
Urology of Indiana, LLC (US Urology Partners)
Greenwood, Indiana, United States
First Urology, PSC
Jeffersonville, Indiana, United States
Urologic Specialists of Northwest Indiana (Solaris)
Merrillville, Indiana, United States
Urology Center of Iowa Research
Clive, Iowa, United States
Wichita Urology Group
Wichita, Kansas, United States
Southern Urology (Urology America)
Lafayette, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Anne Arundel Urology
Annapolis, Maryland, United States
Chesapeake Urology Research Associates
Hanover, Maryland, United States
Comprehensive Urology
Royal Oak, Michigan, United States
Michigan Institute of Urology (Solaris)
Troy, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Minnesota Urology
Woodbury, Minnesota, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States
Adult and Adolescent Urology
Omaha, Nebraska, United States
Integrated Medical Professionals, PLLC (Solaris)
New York, New York, United States
University of Rochester
Rochester, New York, United States
SUNY Upstate
Syracuse, New York, United States
Associated Medical Professionals of NY, PLLC (US Urology Partners)
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Urology Group (Solaris)
Cincinnati, Ohio, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
Central Ohio Urology Group (US Urology Partners)
Gahanna, Ohio, United States
Oregon Urology Institute
Springfield, Oregon, United States
Midlantic Urology (Solaris)
Bala-Cynwyd, Pennsylvania, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Charleston Area Medical Center
Charleston, South Carolina, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
Lowcountry Urology (Solaris)
North Charleston, South Carolina, United States
The Conrad Pearson Clinic (Urology America)
Germantown, Tennessee, United States
Urology Associates, PC
Nashville, Tennessee, United States
Amarillo Urology Research
Amarillo, Texas, United States
UPNT Research Institute, LLC
Arlington, Texas, United States
Urology Austin, PLLC (Urology America)
Austin, Texas, United States
Urology Clinics of North Texas, PLLC
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist
Houston, Texas, United States
Urology San Antonio, PA dba USA Clinical Trials
San Antonio, Texas, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Spokane Urology
Spokane, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Michael G Oefelein, MD
Role: primary
Catherine Rodriguez
Role: primary
Other Identifiers
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CORE-008
Identifier Type: -
Identifier Source: org_study_id
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