Recruiting

Phase 2

Cretostimogene GrenadenorepvecPhase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

Sponsor:

CG Oncology, Inc.

Code:

NCT06567743

Conditions

High-Risk Non-Muscle-Invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cretostimogene Grenadenorepvec

Study Details

Brief summary:

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.

Conditions

High-Risk Non-Muscle-Invasive Bladder Cancer

Study ID

NCT06567743

Start date

Sep 16, 2024

Status verified date

Sep, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Key Exclusion Criteria (Both Cohorts):

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.
Significant immunodeficiency.
Pregnant or breastfeeding.
Cohort CX Only: serial intravesical gemcitabine within 24 months

Study Design

Enrollment

325 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Cohort A, Arm 1

Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method

experimental: Experimental: Cohort A, Arm 2

Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.

experimental: Experimental: Cohort A, Arm 3

Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.

experimental: Experimental: Cohort B, Arm 1

Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.

experimental: Experimental: Cohort B, Arm 2

Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.

experimental: 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

experimental: 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

Interventions

Cretostimogene Grenadenorepvec

Respective Cohort

Primary outcome measure

Cohort A (Arm 1 and 2): Complete response rate [ Time Frame: At 11 and 24 weeks ]
Cohort A (Arm 3): High- Grade Event-Free Survival [ Time Frame: 48 months ]
Cohort B (Arm 1): Complete response rate [ Time Frame: At 11 and 24 weeks ]
Cohort B (Arm 2): High-Grade Event-Free Survival [ Time Frame: 48 months ]
Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival [ Time Frame: 48 months ]
Cohort CX (Arms 1 and 2): Safety [ Time Frame: 48 months ]

Central Contacts and Locations

Central contacts

Rebecca Tregunna, MD

949 409-3700 Rebecca.Tregunna@cgoncology.com

Pat Keegan, MD

949 409-3700 pat.keegan@cgoncology.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Chinedu Mmeje, MD

480-256-6444 Chinedu.Mmeje@bannerhealth.com

Principal Investigator:

Chinedu Mmeje, MD

Mayo Clinic Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Mark Tyson, MD

tyson.mark@mayo.edu

Principal Investigator:

Mark Tyson, MD

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Ahmet Aydin, MD

501-526-5658 maydin@uams.edu

Principal Investigator:

Ahmet Aydin, MD

Arkansas Urology

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Jon Henderson, MD

501-219-8900 Jon@arkansasurology.com

Principal Investigator:

Jon Henderson, MD

Michael G Oefelein, MD Clinical Trials

Recruiting

Bakersfield, California, United States, 93301

Contacts

Michael G Oefelein, MD

661-310-1063

Principal Investigator:

Michael G Oefelein, MD

City of Hope

Recruiting

Irvine, California, United States, 92518

Contacts

Cory Hugen, MD

949-671-4673 chugen@coh.org

Principal Investigator:

Cory Hugen, MD

Genesis Research (Greater Los Angeles)

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Sepehr Nowfar, MD

424-667-2280 Sepehr.Nowfar@uniohp.com

Principal Investigator:

Sepehr Nowfar, MD

Urology Center of Southern California

Recruiting

Murrieta, California, United States, 92563

Contacts

Madhumitha Reddy, MD

mreddy@ucosc.com

Principal Investigator:

Madhumitha Reddy, MD

University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Edward Uchio, MD

euchio@uci.edu

Principal Investigator:

Edward Uchio, MD

UC Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Thenappan Chandrasekar, MD

916-734-5959 tchandrasekar@health.ucdavis.edu

Principal Investigator:

Thenappan Chandrasekar, MD

Om research

Recruiting

San Diego, California, United States, 91223

Contacts

Katayune Golshan

858-429-7050 kgolshan@omclinicaltrials.com

Principal Investigator:

Paul Dato, MD

University of Southern California

Recruiting

San Diego, California, United States, 92123

Contacts

Siamak Daneshmand, MD

daneshma@med.usc.edu

Principal Investigator:

Siamek Daneshmand, MD

Genesis Research (Greater Los Angeles)

Recruiting

Torrance, California, United States, 90503

Contacts

Timothy Lesser, MD

424-667-2565 Timothy.Lesser@uniohp.com

Principal Investigator:

Timothy Lesser, MD

Colorado Urology

Recruiting

Lakewood, Colorado, United States, 80228

Contacts

David Cahn, MD

Dcahn@coloradouro.com

Principal Investigator:

David Cahn, MD

Urology Associates, Lone Tree

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Daniel Mazur, MD

D.Mazur@uradenver.com

Principal Investigator:

Daniel Mazur, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Paul Crispen

352-273-8236 Paul.Crispen@urology.ufl.edu

Principal Investigator:

Padaric O'Malley, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Andrew Zganjar, MD

Zganjar.Andrew@mayo.edu

Principal Investigator:

Andrew Zganjar, MD

Advanced Urology Institute (Solaris)

Recruiting

Largo, Florida, United States, 33771

Contacts

Matthew Truesdale, MD

matthew.truesdale@auihealth.com

Principal Investigator:

Matthew Truesdale, MD

Advanced Urology Institute

Recruiting

Oxford, Florida, United States, 34484

Contacts

Edward King, MD

352-259-4400 edward.king@auihealth.com

Principal Investigator:

Edward King, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Shreyas Joshi, MD

shreyas.joshi@emory.edu

Principal Investigator:

Shreyas Joshi, MD

Associated Urological Specialists

Recruiting

Chicago Ridge, Illinois, United States, 60415

Contacts

Aaron Berger, MD

a.berger@auspecialists.com

Principal Investigator:

Aaron Berger, MD

Uropartners

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Jeffrey Pearl, MD

JPearl@uropartners.com;

Principal Investigator:

Jeffrey Pearl, MD

Accellacare

Recruiting

Lisle, Illinois, United States, 60532

Contacts

Ranko Miocinovic, MD

630-545-7760 Ranko.miocinovic@duly.com

Principal Investigator:

Ranko Miocinovic, MD

Urology of Indiana - Carmel

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Chad Reichard, MD

creichard@urologyin.com

Principal Investigator:

Chad Reichard, MD

Urology of Indiana, LLC (US Urology Partners)

Recruiting

Greenwood, Indiana, United States, 46143

Contacts

Eugene Cone, MD

317-564-5573 econe@urologyin.com

Principal Investigator:

Eugene Cone, MD

First Urology, PSC

Recruiting

Jeffersonville, Indiana, United States, 47130

Contacts

Ryan Malone, MD

812-206-8164 rmalone@1sturology.com

Principal Investigator:

Ryan Malone, MD

Urologic Specialists of Northwest Indiana (Solaris)

Recruiting

Merrillville, Indiana, United States, 46410

Contacts

Manoj Rao, MD

219-769-8641 mrao@urologic-specialists.com

Principal Investigator:

Manoj Rao, MD

Urology Center of Iowa Research

Recruiting

Clive, Iowa, United States, 50325

Contacts

Brian Gallagher, MD

515-992-7718 brian.gallagher@objective.health

Principal Investigator:

Brian Gallagher, MD

Wichita Urology Group

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Philippe Nabbout, MD

pnabbout@wichitaurology.com

Principal Investigator:

Philippe Nabbout, MD

Southern Urology (Urology America)

Recruiting

Lafayette, Louisiana, United States, 70508

Contacts

Jason Bourque, MD

337-422-3738 jasonbourque@gmail.com

Principal Investigator:

Jason Bourque, MD

Ochsner Medical Center

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Kyle Rose, MD

kyle.rose@ochsner.org

Principal Investigator:

Kyle Rose, MD

Anne Arundel Urology

Recruiting

Annapolis, Maryland, United States, 21401

Contacts

Megan Lormore

410-266-8049 mlormore@aaurology.com

Principal Investigator:

Mara Holton, MD

Chesapeake Urology Research Associates

Recruiting

Hanover, Maryland, United States, 21076

Contacts

Rian Dickstein, MD

rdcura@chesuro.com

Principal Investigator:

Rian Dickstein, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Mark Preston, MD

617-525-8274 MPRESTON@BWH.HARVARD.EDU

Principal Investigator:

Mark Preston, MD

Comprehensive Urology

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Tarek Sangid

248-336-1080 TSangid@urologist.org

Principal Investigator:

Adam Gadzinski, MD

Michigan Institute of Urology (Solaris)

Recruiting

Troy, Michigan, United States, 48084

Contacts

Jason Hafron, MD

248-786-0467 HafronJ@michiganurology.com

Principal Investigator:

Jason Hafron, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Paras Shah, MD

Shah.Paras@mayo.edu

Principal Investigator:

Paras Shah, MD

Minnesota Urology

Recruiting

Woodbury, Minnesota, United States, 55123

Contacts

Aaron Milbank, MD

651-999-6800 amilbank@mnurology.com

Principal Investigator:

Aaron Milbank, MD

Specialty Clinical Research of St. Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Gregory Auffenberg, MD

Gregory.Auffenberg@objective.health

Principal Investigator:

Gregory Auffenberg, MD

Adult and Adolescent Urology

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Andrew Trainer, MD

atrainer@adultpediatricuro.com

Principal Investigator:

Andrew Trainer, MD

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Nitin Yerram, MD

551-996-8090 nitin.yerram@hmhn.org

Principal Investigator:

Nitin Yerram, MD

Integrated Medical Professionals, PLLC (Solaris)

Recruiting

New York, New York, United States, 10016

Contacts

Jed Kaminetsky, MD

jkaminetsky@imppllc.com

Principal Investigator:

Jed Kaminetsky, MD

University of Rochester

Recruiting

Rochester, New York, United States, 14620

Contacts

William Tabayoyong, MD

william_tabayoyong@urmc.rochester.edu

Principal Investigator:

William Tabayoyong, MD

SUNY Upstate

Recruiting

Syracuse, New York, United States, 13202

Contacts

Joseph Jacob, MD

jacobj@upstate.edu

Principal Investigator:

Joseph Jacob, MD

Associated Medical Professionals of NY, PLLC (US Urology Partners)

Recruiting

Syracuse, New York, United States, 13210

Contacts

Christopher Pieczonka, MD

315-478-4185 cpieczonka@ampofny.com

Principal Investigator:

Christopher Pieczonka, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Alexander Sankin, MD

347-842-1700 asankin@montefiore.org

Principal Investigator:

Alexander Sankin, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Principal Investigator:

Mary Westerman, MD

Atrium Health/Levine Center

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Justin Matulay, MD

980-442-2000 Justin.Matulay@atriumhealth.org

Principal Investigator:

Justin Matulay, MD

Associated Urologist of North Carolina (Solaris)

Recruiting

Raleigh, North Carolina, United States, 27612

Contacts

Mark Jalkut, MD

919-782-1255 MJalkut@auncurology.com

Principal Investigator:

Mark Jalkut, MD

The Urology Group (Solaris)

Recruiting

Cincinnati, Ohio, United States, 45212

Contacts

Marc Pliskin, MD

mpliskin@urologygroup.com

Principal Investigator:

Marc Pliskin, MD

University of Cincinnati Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Alberto Martini, MD

651-999-6800 marti9a7@ucmail.uc.edu

Principal Investigator:

Alberto Martini, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Laura Bukavina, MD

216-444-2200 bukavil2@ccf.org

Principal Investigator:

Laura Bukavina, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Deb Sundi, MD

614-685-4263 D.Sundi@osumc.edu

Principal Investigator:

Deb Sundi, MD

Central Ohio Urology Group (US Urology Partners)

Recruiting

Gahanna, Ohio, United States, 43230

Contacts

Benjamin Martin, MD

614-396-2684 bmartin@centralohiourology.com

Principal Investigator:

Benjamin Martin, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jen-Jane Lui, MD

503-346-0640 jenj@ohsu.edu

Principal Investigator:

Jen-Jabe Lui, ND

Portland VA

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Nicholas Chakiryan, MD

Oregon Urology Institute

Recruiting

Springfield, Oregon, United States, 97447

Contacts

Katareanna Jeudy

541-284-5508 kjeudy@oregonurology.com

Principal Investigator:

Bryan Mehlhaff, MD

Midlantic Urology (Solaris)

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Contacts

Laurence Belkoff, MD

lbelkoff@midlanticurology.com

Principal Investigator:

Laurence Belkoff, MD

Penn State University Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Susan Godfrey

717-531-4472 sgodfrey@pennstatehealth.psu.edu

Principal Investigator:

Jay Raman, MD

Keystone Urology Specialists

Recruiting

Lancaster, Pennsylvania, United States, 17604

Contacts

Kenneth Lessans, MD

klessans@midlanticurology.com

Principal Investigator:

Kenneth Lessans, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Trinity Bivalacqua, MD

trinity.bivalacqua@pennmedicine.upenn.edu

Principal Investigator:

Trinity Bivalacqua, MD

Charleston Area Medical Center

Recruiting

Charleston, South Carolina, United States, 25304

Contacts

Michael Stencel, MD

Michael.stenceldo@gmail.com

Principal Investigator:

Michael Stencel, MD

Carolina Urologic Research Center, LLC

Recruiting

Myrtle Beach, South Carolina, United States, 229572

Contacts

Neal Shore, MD

nshore@gsuro.com

Principal Investigator:

Neal Shore, MD

Lowcountry Urology (Solaris)

Recruiting

North Charleston, South Carolina, United States, 29406

Contacts

Justin Ellett, MD

jellett@lcurology.com

Principal Investigator:

Justin Ellett, MD

The Conrad Pearson Clinic (Urology America)

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Michael Granieri, MD

901-236-0957 mgranieri@conradpearson.com

Principal Investigator:

Michael Granieri, MD

Urology Associates, PC

Recruiting

Nashville, Tennessee, United States, 37209

Contacts

Gautam Jayram, MD

615-250-9208 gtjayram@ua-pc.com

Principal Investigator:

Gautam Jayram, MD

UPNT Research Institute, LLC

Recruiting

Arlington, Texas, United States, 76017

Contacts

Michael Collini, MD

682-205-8396 michael.collini@objective.health

Principal Investigator:

Michael Collini, MD

Urology Austin, PLLC (Urology America)

Recruiting

Austin, Texas, United States, 78745

Contacts

Brian Mazzarella, MD

512-410-3773 brian.mazzarella@urologyaustin.com

Principal Investigator:

Brian Mazzarella

Urology Clinics of North Texas, PLLC

Recruiting

Dallas, Texas, United States, 75231

Contacts

Jacob Taylor, MD

214-556-8337 jtaylor@urologyclinics.com

Principal Investigator:

Jacob Taylor, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Catherine Rodriguez

214-645-8787

Principal Investigator:

Solomon Woldu, MD

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Dharam Kaushik, MD

kaushik@uthscsa.edu

Principal Investigator:

Dharam Kaushik, MD

Urology San Antonio, PA dba USA Clinical Trials

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Daniel Zainfeld, MD

210-617-4116 Daniel.Zainfeld@urologysa.com

Principal Investigator:

Daniel Zainfeld, MD

Potomac Urology

Recruiting

Alexandria, Virginia, United States, 22311

Contacts

Aseem Malhotra, MD

703-680-2111 amalhotra@potomacurology.com

Principal Investigator:

Aseem Malhotra, MD

Urology of Virginia

Recruiting

Virginia Beach, Virginia, United States, 23462

Contacts

Michael Williams, MD

mwilliams@urologyofva.net

Principal Investigator:

Williams Michael, MD

Spokane Urology

Recruiting

Spokane, Washington, United States, 99202

Contacts

Shane Pearce, MD

509-747-3147 pearce.shane@gmail.com

Principal Investigator:

Shane Pearce, MD

Centre of Applied Urology Research Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Ricardo Rendon, MD

902.425.3940 ricardo.rendon@dal.ca

Principal Investigator:

Ricardo Rendon, MD

More Information

Sponsor

CG Oncology, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

Bladder Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by CG Oncology, Inc. on 2026-09-03.