NCT06567743RecruitingPhase 2
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 325 (estimated)
- First submitted
- 14 Aug 2024
- Start date
- 16 Sept 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- CG Oncology, Inc.
- Diseases
- Bladder cancer
- NCT number
- NCT06567743
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 325
- From 16 Sept 2024 to the primary completion date, 31 Mar 2027
- 80 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.
- 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.
Other
- Significant immunodeficiency.
- Pregnant or breastfeeding.
- Cohort CX Only: serial intravesical gemcitabine within 24 months
Criteria the registry did not label
- Cohort A Key Inclusion Criteria:
- Pathologically confirmed BCG-naïve 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.
- Cohort B Key Inclusion Criteria:
- 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.
- Cohort CX Inclusion Criteria
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (80)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre of Applied Urology Research/Nova Scotia Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| Potomac Urology Coordinator of this site? Confirm its status | Alexandria | United States | Recruiting |
| Amarillo Urology Research Coordinator of this site? Confirm its status | Amarillo | United States | Completed |
| Anne Arundel Urology Coordinator of this site? Confirm its status | Annapolis | United States | Recruiting |
| UPNT Research Institute, LLC Coordinator of this site? Confirm its status | Arlington | United States | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Urology Austin, PLLC (Urology America) Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Michael G Oefelein, MD Clinical Trials Coordinator of this site? Confirm its status | Bakersfield | United States | Recruiting |
| Midlantic Urology (Solaris) Coordinator of this site? Confirm its status | Bala-Cynwyd | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Urology of Indiana - Carmel Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Charleston Area Medical Center Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Atrium Health/Levine Center Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Associated Urological Specialists Coordinator of this site? Confirm its status | Chicago Ridge | United States | Recruiting |
| The Urology Group (Solaris) Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| University of Cincinnati Cancer Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Urology Center of Iowa Research Coordinator of this site? Confirm its status | Clive | United States | Recruiting |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Urology Clinics of North Texas, PLLC Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Central Ohio Urology Group (US Urology Partners) Coordinator of this site? Confirm its status | Gahanna | United States | Recruiting |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| The Conrad Pearson Clinic (Urology America) Coordinator of this site? Confirm its status | Germantown | United States | Recruiting |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Recruiting |
| UroPartners Coordinator of this site? Confirm its status | Glenview | United States | Recruiting |
| Urology of Indiana, LLC (US Urology Partners) Coordinator of this site? Confirm its status | Greenwood | United States | Recruiting |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Chesapeake Urology Research Associates Coordinator of this site? Confirm its status | Hanover | United States | Recruiting |
| Penn State University Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Recruiting |
| Houston Methodist Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Mayo Clinic Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| First Urology, PSC Coordinator of this site? Confirm its status | Jeffersonville | United States | Recruiting |
| Southern Urology (Urology America) Coordinator of this site? Confirm its status | Lafayette | United States | Recruiting |
| Colorado Urology Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Keystone Urology Specialists Coordinator of this site? Confirm its status | Lancaster | United States | Recruiting |
| Advanced Urology Institute (Solaris) Coordinator of this site? Confirm its status | Largo | United States | Recruiting |
| Accellacare Coordinator of this site? Confirm its status | Lisle | United States | Recruiting |
| Arkansas Urology Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Urology Associates, Lone Tree Coordinator of this site? Confirm its status | Lone Tree | United States | Recruiting |
| Genesis Research (Greater Los Angeles) Coordinator of this site? Confirm its status | Los Alamitos | United States | Recruiting |
| Advanced Urology Coordinator of this site? Confirm its status | Los Angeles | United States | Withdrawn |
| Urologic Specialists of Northwest Indiana (Solaris) Coordinator of this site? Confirm its status | Merrillville | United States | Recruiting |
| Urology Center of Southern California Coordinator of this site? Confirm its status | Murrieta | United States | Recruiting |
| Carolina Urologic Research Center, LLC Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| Urology Associates PC Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Ochsner Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Integrated Medical Professionals, PLLC (Solaris) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Lowcountry Urology (Solaris) Coordinator of this site? Confirm its status | North Charleston | United States | Recruiting |
| Adult and Adolescent Urology Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Advanced Urology Institute Coordinator of this site? Confirm its status | Oxford | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Portland VA Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Associated Urologist of North Carolina (Solaris) Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Comprehensive Urology Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| UC Davis Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Urology San Antonio, PA dba USA Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Om Research Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| University of Southern California Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Spokane Urology Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Oregon Urology Institute Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Specialty Clinical Research of St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Associated Medical Professionals of NY, PLLC (US Urology Partners) Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| SUNY Upstate Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Advanced Urology Institute - Tallahassee (Solaris) Coordinator of this site? Confirm its status | Tallahassee | United States | Withdrawn |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Genesis Research (Greater Los Angeles) Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
| Michigan Institute of Urology (Solaris) Coordinator of this site? Confirm its status | Troy | United States | Recruiting |
| Arizona Urology Specialty Coordinator of this site? Confirm its status | Tucson | United States | Withdrawn |
| Urology of Virginia Coordinator of this site? Confirm its status | Virginia Beach | United States | Recruiting |
| Wichita Urology Group Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
| Minnesota Urology Coordinator of this site? Confirm its status | Woodbury | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.