Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- CG Oncology, Inc.
- Study ID
- NCT06567743
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- High-Risk Non-Muscle-Invasive Bladder Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cretostimogene Grenadenorepvec — DRUGRespective Cohort
Study Details
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.
Key Dates
- Start date
- Sep 16, 2024
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2027
- Completion
- Dec 30, 2027
Study Design
- Enrollment
- 325 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental: Cohort A, Arm 1Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method
- Experimental: Experimental: Cohort A, Arm 2Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
- Experimental: Experimental: Cohort A, Arm 3Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
- Experimental: Experimental: Cohort B, Arm 1Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
- Experimental: Experimental: Cohort B, Arm 2Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
- Experimental: Experimental: Cohort CX, Arm 1At all treatment visits cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method followed by gemcitabine instilled intravesically
- Experimental: Experimental: Cohort CX, Arm 2Cretostimogene (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
Primary Outcome Measure
Cohort A (Arm 1 and 2): Complete response rate [ Time Frame: At 11 and 24 weeks ]
Central Contacts
- Rebecca Tregunna, MD949 409-3700
- Pat Keegan, MD949 409-3700
Locations (65)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | Mark Tyson, MD Mark Tyson, MD (PRINCIPAL_INVESTIGATOR) |
| Arizona Urology Specialty | Tucson | Arizona | 85704 | - |
| Arkansas Urology | Little Rock | Arkansas | 72211 | Jon Henderson, MD (PRINCIPAL_INVESTIGATOR) |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | Ahmet Aydin, MD (PRINCIPAL_INVESTIGATOR) |
| Michael G Oefelein, MD Clinical Trials | Bakersfield | California | 93301 | Michael G Oefelein, MD 661-310-1063 Michael G Oefelein, MD (PRINCIPAL_INVESTIGATOR) |
| Genesis Research (Greater Los Angeles) | Los Alamitos | California | 90720 | Sepehr Nowfar, MD (PRINCIPAL_INVESTIGATOR) |
| Advanced Urology | Los Angeles | California | 90045 | - |
| Urology Center of Southern California | Murrieta | California | 92563 | Madhumitha Reddy, MD Madhumitha Reddy, MD (PRINCIPAL_INVESTIGATOR) |
| University of California, Irvine | Orange | California | 92868 | Edward Uchio, MD Edward Uchio, MD (PRINCIPAL_INVESTIGATOR) |
| Om research | San Diego | California | 91223 | Paul Dato, MD (PRINCIPAL_INVESTIGATOR) |
| University of Southern California | San Diego | California | 92123 | Siamak Daneshmand, MD Siamek Daneshmand, MD (PRINCIPAL_INVESTIGATOR) |
| Genesis Research (Greater Los Angeles) | Torrance | California | 90503 | Timothy Lesser, MD (PRINCIPAL_INVESTIGATOR) |
| Colorado Urology | Lakewood | Colorado | 80228 | David Cahn, MD David Cahn, MD (PRINCIPAL_INVESTIGATOR) |
| Urology Associates, Lone Tree | Lone Tree | Colorado | 80124 | Daniel Mazur, MD Daniel Mazur, MD (PRINCIPAL_INVESTIGATOR) |
| University of Florida | Gainesville | Florida | 32611 | Padaric O'Malley, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Andrew Zganjar, MD Andrew Zganjar, MD (PRINCIPAL_INVESTIGATOR) |
| Advanced Urology Institute (Solaris) | Largo | Florida | 33771 | Matthew Truesdale, MD Matthew Truesdale, MD (PRINCIPAL_INVESTIGATOR) |
| Advanced Urology Institute | Oxford | Florida | 34484 | Edward King, MD (PRINCIPAL_INVESTIGATOR) |
| Advanced Urology Institute - Tallahassee (Solaris) | Tallahassee | Florida | 32308 | - |
| Emory University | Atlanta | Georgia | 30322 | Shreyas Joshi, MD Shreyas Joshi, MD (PRINCIPAL_INVESTIGATOR) |
| Associated Urological Specialists | Chicago Ridge | Illinois | 60415 | Aaron Berger, MD Aaron Berger, MD (PRINCIPAL_INVESTIGATOR) |
| Uropartners | Glenview | Illinois | 60026 | Jeffrey Pearl, MD Jeffrey Pearl, MD (PRINCIPAL_INVESTIGATOR) |
| Urology of Indiana - Carmel | Carmel | Indiana | 46032 | Chad Reichard, MD Chad Reichard, MD (PRINCIPAL_INVESTIGATOR) |
| Urology of Indiana, LLC (US Urology Partners) | Greenwood | Indiana | 46143 | Eugene Cone, MD (PRINCIPAL_INVESTIGATOR) |
| First Urology, PSC | Jeffersonville | Indiana | 47130 | Ryan Malone, MD (PRINCIPAL_INVESTIGATOR) |
| Urologic Specialists of Northwest Indiana (Solaris) | Merrillville | Indiana | 46410 | Manoj Rao, MD (PRINCIPAL_INVESTIGATOR) |
| Urology Center of Iowa Research | Clive | Iowa | 50325 | Brian Gallagher, MD (PRINCIPAL_INVESTIGATOR) |
| Wichita Urology Group | Wichita | Kansas | 67226 | Philippe Nabbout, MD Philippe Nabbout, MD (PRINCIPAL_INVESTIGATOR) |
| Southern Urology (Urology America) | Lafayette | Louisiana | 70508 | Jason Bourque, MD (PRINCIPAL_INVESTIGATOR) |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | Kyle Rose, MD Kyle Rose, MD (PRINCIPAL_INVESTIGATOR) |
| Anne Arundel Urology | Annapolis | Maryland | 21401 | Mara Holton, MD (PRINCIPAL_INVESTIGATOR) |
| Chesapeake Urology Research Associates | Hanover | Maryland | 21076 | Rian Dickstein, MD Rian Dickstein, MD (PRINCIPAL_INVESTIGATOR) |
| Comprehensive Urology | Royal Oak | Michigan | 48073 | Adam Gadzinski, MD (PRINCIPAL_INVESTIGATOR) |
| Michigan Institute of Urology (Solaris) | Troy | Michigan | 48084 | Jason Hafron, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Paras Shah, MD Paras Shah, MD (PRINCIPAL_INVESTIGATOR) |
| Minnesota Urology | Woodbury | Minnesota | 55123 | Aaron Milbank, MD (PRINCIPAL_INVESTIGATOR) |
| Specialty Clinical Research of St. Louis | St Louis | Missouri | 63141 | Gregory Auffenberg, MD Gregory Auffenberg, MD (PRINCIPAL_INVESTIGATOR) |
| Adult and Adolescent Urology | Omaha | Nebraska | 68114 | Andrew Trainer, MD Andrew Trainer, MD (PRINCIPAL_INVESTIGATOR) |
| Integrated Medical Professionals, PLLC (Solaris) | New York | New York | 10016 | Jed Kaminetsky, MD Jed Kaminetsky, MD (PRINCIPAL_INVESTIGATOR) |
| University of Rochester | Rochester | New York | 14620 | William Tabayoyong, MD William Tabayoyong, MD (PRINCIPAL_INVESTIGATOR) |
| Associated Medical Professionals of NY, PLLC (US Urology Partners) | Syracuse | New York | 13210 | Christopher Pieczonka, MD (PRINCIPAL_INVESTIGATOR) |
| SUNY Upstate | Syracuse | New York | 13202 | Joseph Jacob, MD Joseph Jacob, MD (PRINCIPAL_INVESTIGATOR) |
| Montefiore Medical Center | The Bronx | New York | 10461 | Alexander Sankin, MD (PRINCIPAL_INVESTIGATOR) |
| The Urology Group (Solaris) | Cincinnati | Ohio | 45212 | Marc Pliskin, MD Marc Pliskin, MD (PRINCIPAL_INVESTIGATOR) |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45267 | Alberto Martini, MD (PRINCIPAL_INVESTIGATOR) |
| Central Ohio Urology Group (US Urology Partners) | Gahanna | Ohio | 43230 | Benjamin Martin, MD (PRINCIPAL_INVESTIGATOR) |
| Oregon Urology Institute | Springfield | Oregon | 97447 | Bryan Mehlhaff, MD (PRINCIPAL_INVESTIGATOR) |
| Midlantic Urology (Solaris) | Bala-Cynwyd | Pennsylvania | 19004 | Laurence Belkoff, MD Laurence Belkoff, MD (PRINCIPAL_INVESTIGATOR) |
| Penn State University Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | Jay Raman, MD (PRINCIPAL_INVESTIGATOR) |
| Keystone Urology Specialists | Lancaster | Pennsylvania | 17604 | Paul Sieber, MD Paul Sieber, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Trinity Bivalacqua, MD Trinity Bivalacqua, MD (PRINCIPAL_INVESTIGATOR) |
| Charleston Area Medical Center | Charleston | South Carolina | 25304 | Michael Stencel, MD Michael Stencel, MD (PRINCIPAL_INVESTIGATOR) |
| Carolina Urologic Research Center, LLC | Myrtle Beach | South Carolina | 229572 | Neal Shore, MD Neal Shore, MD (PRINCIPAL_INVESTIGATOR) |
| Lowcountry Urology (Solaris) | North Charleston | South Carolina | 29406 | Justin Ellett, MD Justin Ellett, MD (PRINCIPAL_INVESTIGATOR) |
| The Conrad Pearson Clinic (Urology America) | Germantown | Tennessee | 38138 | Michael Granieri, MD (PRINCIPAL_INVESTIGATOR) |
| Urology Associates, PC | Nashville | Tennessee | 37209 | Gautam Jayram, MD (PRINCIPAL_INVESTIGATOR) |
| Amarillo Urology Research | Amarillo | Texas | 79106 | - |
| UPNT Research Institute, LLC | Arlington | Texas | 76017 | Michael Collini, MD (PRINCIPAL_INVESTIGATOR) |
| Urology Austin, PLLC (Urology America) | Austin | Texas | 78745 | Brian Mazzarella (PRINCIPAL_INVESTIGATOR) |
| Urology Clinics of North Texas, PLLC | Dallas | Texas | 75231 | Jacob Taylor, MD (PRINCIPAL_INVESTIGATOR) |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Catherine Rodriguez 214-645-8787 Solomon Woldu, MD (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist | Houston | Texas | 77030 | Raj Satkunasivam, MD Raj Satkunasivam, MD (PRINCIPAL_INVESTIGATOR) |
| Urology San Antonio, PA dba USA Clinical Trials | San Antonio | Texas | 78229 | Daniel Zainfeld, MD (PRINCIPAL_INVESTIGATOR) |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | Michael Williams, MD Williams Michael, MD (PRINCIPAL_INVESTIGATOR) |
| Spokane Urology | Spokane | Washington | 99202 | Shane Pearce, MD (PRINCIPAL_INVESTIGATOR) |