Cretostimogene Grenadenorepvec in High-Risk NMIBC

INTRODUCTION

Org Study ID: CORE-008
Secondary ID: N/A
NCT ID: NCT06567743
Sponsor: CG Oncology, Inc.

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.

In Cohort A, up to 125 participants will be enrolled with pathologically confirmed, high-risk high-grade non-muscle invasive bladder cancer (NMIBC) NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which is naïve to Bacillus Calmette-Guerin (BCG) treatment. Participants with CIS with or without concomitant Ta/T1 NMIBC at baseline will be randomized 1:1 to receive cretostimogene via the current (Arm 1) or an alternative instillation procedure (Arm 2). Participants with papillary-only high-risk NMIBC (i.e., HG Ta/T1 without CIS) at baseline (Arm 3) will receive cretostimogene via the alternative instillation procedure.

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.

Overall Status
Recruiting
Start Date
September 16, 2024
Phase
Phase 2
Study Type
Interventional

Primary Outcome 1 - Measure: Cohort A (Arm 1 and 2): Complete response rate

Primary Outcome 1 - Timeframe: At 11 and 24 weeks

Primary Outcome 2 - Measure: Cohort A (Arm 3): High- Grade Event-Free Survival

Primary Outcome 2 - Timeframe: 48 months

Primary Outcome 3 - Measure: Cohort B (Arm 1): Complete response rate

Primary Outcome 3 - Timeframe: At 11 and 24 weeks

Primary Outcome 4 - Measure: Cohort B (Arm 2): High-Grade Event-Free Survival

Primary Outcome 4 - Timeframe: 48 months

Primary Outcome 5 - Measure: Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival

Primary Outcome 5 - Timeframe: 48 months

Primary Outcome 6 - Measure: Cohort CX (Arms 1 and 2): Safety

Primary Outcome 6 - Timeframe: 48 months

High-Risk Non-Muscle-Invasive Bladder Cancer

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Name: Vijay Kasturi, MD

Role: Study Director

Affiliation: CG Oncology

Name: Rebecca Tregunna, MD, Pat Keegan, MD

Phone: 949 409-3700, 949 409-3700

Email: [email protected], [email protected]

Facility	Status	Contact
Facility: Mayo Clinic Arizona Phoenix, Arizona 85054 United States	Status: Recruiting	Contact: Contact Mark Tyson, MD [email protected] Principal Investigator Mark Tyson, MD
Facility: University of Arkansas for Medical Sciences Little Rock, Arkansas 72205 United States	Status: Recruiting	Contact: Contact Ahmet Aydin, MD 501-526-5658 [email protected] Principal Investigator Ahmet Aydin, MD
Facility: Arkansas Urology Little Rock, Arkansas 72211 United States	Status: Recruiting	Contact: Contact Jon Henderson, MD 501-219-8900 [email protected] Principal Investigator Jon Henderson, MD
Facility: Michael G Oefelein, MD Clinical Trials Bakersfield, California 93301 United States	Status: Recruiting	Contact: Contact Michael G Oefelein, MD 661-310-1063 Principal Investigator Michael G Oefelein, MD
Facility: Genesis Research (Greater Los Angeles) Los Alamitos, California 90720 United States	Status: Recruiting	Contact: Contact Sepehr Nowfar, MD 424-667-2280 [email protected] Principal Investigator Sepehr Nowfar, MD
Facility: Urology Center of Southern California Murrieta, California 92563 United States	Status: Recruiting	Contact: Contact Madhumitha Reddy, MD [email protected] Principal Investigator Madhumitha Reddy, MD
Facility: University of California, Irvine Orange, California 92868 United States	Status: Recruiting	Contact: Contact Edward Uchio, MD [email protected] Principal Investigator Edward Uchio, MD
Facility: Om research San Diego, California 91223 United States	Status: Recruiting	Contact: Contact Katayune Golshan 858-429-7050 2668 [email protected] Principal Investigator Paul Dato, MD
Facility: University of Southern California San Diego, California 92123 United States	Status: Recruiting	Contact: Contact Siamak Daneshmand, MD [email protected] Principal Investigator Siamek Daneshmand, MD
Facility: Genesis Research (Greater Los Angeles) Torrance, California 90503 United States	Status: Recruiting	Contact: Contact Timothy Lesser, MD 424-667-2565 [email protected] Principal Investigator Timothy Lesser, MD
Facility: Colorado Urology Lakewood, Colorado 80228 United States	Status: Recruiting	Contact: Contact David Cahn, MD [email protected] Principal Investigator David Cahn, MD
Facility: Urology Associates, Lone Tree Lone Tree, Colorado 80124 United States	Status: Recruiting	Contact: Contact Daniel Mazur, MD [email protected] Principal Investigator Daniel Mazur, MD
Facility: University of Florida Gainesville, Florida 32611 United States	Status: Recruiting	Contact: Contact Paul Crispen 352-273-8236 [email protected] Principal Investigator Padaric O'Malley, MD
Facility: Mayo Clinic Florida Jacksonville, Florida 32224 United States	Status: Recruiting	Contact: Contact Andrew Zganjar, MD [email protected] Principal Investigator Andrew Zganjar, MD
Facility: Advanced Urology Institute (Solaris) Largo, Florida 33771 United States	Status: Recruiting	Contact: Contact Matthew Truesdale, MD [email protected] Principal Investigator Matthew Truesdale, MD
Facility: Advanced Urology Institute Oxford, Florida 34484 United States	Status: Recruiting	Contact: Contact Edward King, MD 352-259-4400 [email protected] Principal Investigator Edward King, MD
Facility: Emory University Atlanta, Georgia 30322 United States	Status: Recruiting	Contact: Contact Shreyas Joshi, MD [email protected] Principal Investigator Shreyas Joshi, MD
Facility: Associated Urological Specialists Chicago Ridge, Illinois 60415 United States	Status: Recruiting	Contact: Contact Aaron Berger, MD [email protected] Principal Investigator Aaron Berger, MD
Facility: Uropartners Glenview, Illinois 60026 United States	Status: Recruiting	Contact: Contact Jeffrey Pearl, MD [email protected]; Principal Investigator Jeffrey Pearl, MD
Facility: Urology of Indiana - Carmel Carmel, Indiana 46032 United States	Status: Recruiting	Contact: Contact Chad Reichard, MD [email protected] Principal Investigator Chad Reichard, MD
Facility: Urology of Indiana, LLC (US Urology Partners) Greenwood, Indiana 46143 United States	Status: Recruiting	Contact: Contact Eugene Cone, MD 317-564-5573 [email protected] Principal Investigator Eugene Cone, MD
Facility: First Urology, PSC Jeffersonville, Indiana 47130 United States	Status: Recruiting	Contact: Contact Ryan Malone, MD 812-206-8164 [email protected] Principal Investigator Ryan Malone, MD
Facility: Urologic Specialists of Northwest Indiana (Solaris) Merrillville, Indiana 46410 United States	Status: Recruiting	Contact: Contact Manoj Rao, MD 219-769-8641 [email protected] Principal Investigator Manoj Rao, MD
Facility: Urology Center of Iowa Research Clive, Iowa 50325 United States	Status: Recruiting	Contact: Contact Brian Gallagher, MD 515-992-7718 [email protected] Principal Investigator Brian Gallagher, MD
Facility: Wichita Urology Group Wichita, Kansas 67226 United States	Status: Recruiting	Contact: Contact Philippe Nabbout, MD [email protected] Principal Investigator Philippe Nabbout, MD
Facility: Southern Urology (Urology America) Lafayette, Louisiana 70508 United States	Status: Recruiting	Contact: Contact Jason Bourque, MD 337-422-3738 [email protected] Principal Investigator Jason Bourque, MD
Facility: Ochsner Medical Center New Orleans, Louisiana 70121 United States	Status: Recruiting	Contact: Contact Kyle Rose, MD [email protected] Principal Investigator Kyle Rose, MD
Facility: Anne Arundel Urology Annapolis, Maryland 21401 United States	Status: Recruiting	Contact: Contact Megan Lormore 410-266-8049 139 [email protected] Principal Investigator Mara Holton, MD
Facility: Chesapeake Urology Research Associates Hanover, Maryland 21076 United States	Status: Recruiting	Contact: Contact Rian Dickstein, MD [email protected] Principal Investigator Rian Dickstein, MD
Facility: Comprehensive Urology Royal Oak, Michigan 48073 United States	Status: Recruiting	Contact: Contact Tarek Sangid 248-336-1080 58754 [email protected] Principal Investigator Adam Gadzinski, MD
Facility: Michigan Institute of Urology (Solaris) Troy, Michigan 48084 United States	Status: Recruiting	Contact: Contact Jason Hafron, MD 248-786-0467 [email protected] Principal Investigator Jason Hafron, MD
Facility: Mayo Clinic Rochester Rochester, Minnesota 55905 United States	Status: Recruiting	Contact: Contact Paras Shah, MD [email protected] Principal Investigator Paras Shah, MD
Facility: Minnesota Urology Woodbury, Minnesota 55123 United States	Status: Recruiting	Contact: Contact Aaron Milbank, MD 651-999-6800 [email protected] Principal Investigator Aaron Milbank, MD
Facility: Specialty Clinical Research of St. Louis St Louis, Missouri 63141 United States	Status: Recruiting	Contact: Contact Gregory Auffenberg, MD [email protected] Principal Investigator Gregory Auffenberg, MD
Facility: Adult and Adolescent Urology Omaha, Nebraska 68114 United States	Status: Recruiting	Contact: Contact Andrew Trainer, MD [email protected] Principal Investigator Andrew Trainer, MD
Facility: Integrated Medical Professionals, PLLC (Solaris) New York, New York 10016 United States	Status: Recruiting	Contact: Contact Jed Kaminetsky, MD [email protected] Principal Investigator Jed Kaminetsky, MD
Facility: University of Rochester Rochester, New York 14620 United States	Status: Recruiting	Contact: Contact William Tabayoyong, MD [email protected] Principal Investigator William Tabayoyong, MD
Facility: SUNY Upstate Syracuse, New York 13202 United States	Status: Recruiting	Contact: Contact Joseph Jacob, MD [email protected] Principal Investigator Joseph Jacob, MD
Facility: Associated Medical Professionals of NY, PLLC (US Urology Partners) Syracuse, New York 13210 United States	Status: Recruiting	Contact: Contact Christopher Pieczonka, MD 315-478-4185 [email protected] Principal Investigator Christopher Pieczonka, MD
Facility: Montefiore Medical Center The Bronx, New York 10461 United States	Status: Recruiting	Contact: Contact Alexander Sankin, MD 347-842-1700 [email protected] Principal Investigator Alexander Sankin, MD
Facility: The Urology Group (Solaris) Cincinnati, Ohio 45212 United States	Status: Recruiting	Contact: Contact Marc Pliskin, MD [email protected] Principal Investigator Marc Pliskin, MD
Facility: University of Cincinnati Cancer Center Cincinnati, Ohio 45267 United States	Status: Recruiting	Contact: Contact Alberto Martini, MD 651-999-6800 [email protected] Principal Investigator Alberto Martini, MD
Facility: Central Ohio Urology Group (US Urology Partners) Gahanna, Ohio 43230 United States	Status: Recruiting	Contact: Contact Benjamin Martin, MD 614-396-2684 [email protected] Principal Investigator Benjamin Martin, MD
Facility: Oregon Urology Institute Springfield, Oregon 97447 United States	Status: Recruiting	Contact: Contact Katareanna Jeudy 541-284-5508 [email protected] Principal Investigator Bryan Mehlhaff, MD
Facility: Midlantic Urology (Solaris) Bala-Cynwyd, Pennsylvania 19004 United States	Status: Recruiting	Contact: Contact Laurence Belkoff, MD [email protected] Principal Investigator Laurence Belkoff, MD
Facility: Penn State University Milton S. Hershey Medical Center Hershey, Pennsylvania 17033 United States	Status: Recruiting	Contact: Contact Susan Godfrey 717-531-4472 [email protected] Principal Investigator Jay Raman, MD
Facility: Keystone Urology Specialists Lancaster, Pennsylvania 17604 United States	Status: Recruiting	Contact: Contact Paul Sieber, MD [email protected] Principal Investigator Paul Sieber, MD
Facility: University of Pennsylvania Philadelphia, Pennsylvania 19104 United States	Status: Recruiting	Contact: Contact Trinity Bivalacqua, MD [email protected] Principal Investigator Trinity Bivalacqua, MD
Facility: Charleston Area Medical Center Charleston, South Carolina 25304 United States	Status: Recruiting	Contact: Contact Michael Stencel, MD [email protected] Principal Investigator Michael Stencel, MD
Facility: Carolina Urologic Research Center, LLC Myrtle Beach, South Carolina 229572 United States	Status: Recruiting	Contact: Contact Neal Shore, MD [email protected] Principal Investigator Neal Shore, MD
Facility: Lowcountry Urology (Solaris) North Charleston, South Carolina 29406 United States	Status: Recruiting	Contact: Contact Justin Ellett, MD [email protected] Principal Investigator Justin Ellett, MD
Facility: The Conrad Pearson Clinic (Urology America) Germantown, Tennessee 38138 United States	Status: Recruiting	Contact: Contact Michael Granieri, MD 901-236-0957 [email protected] Principal Investigator Michael Granieri, MD
Facility: Urology Associates, PC Nashville, Tennessee 37209 United States	Status: Recruiting	Contact: Contact Gautam Jayram, MD 615-250-9208 [email protected] Principal Investigator Gautam Jayram, MD
Facility: UPNT Research Institute, LLC Arlington, Texas 76017 United States	Status: Recruiting	Contact: Contact Michael Collini, MD 682-205-8396 [email protected] Principal Investigator Michael Collini, MD
Facility: Urology Austin, PLLC (Urology America) Austin, Texas 78745 United States	Status: Recruiting	Contact: Contact Brian Mazzarella, MD 512-410-3773 [email protected] Principal Investigator Brian Mazzarella
Facility: Urology Clinics of North Texas, PLLC Dallas, Texas 75231 United States	Status: Recruiting	Contact: Contact Jacob Taylor, MD 214-556-8337 [email protected] Principal Investigator Jacob Taylor, MD
Facility: UT Southwestern Medical Center Dallas, Texas 75390 United States	Status: Recruiting	Contact: Contact Catherine Rodriguez 214-645-8787 Principal Investigator Solomon Woldu, MD
Facility: Houston Methodist Houston, Texas 77030 United States	Status: Recruiting	Contact: Contact Raj Satkunasivam, MD [email protected] Principal Investigator Raj Satkunasivam, MD
Facility: Urology San Antonio, PA dba USA Clinical Trials San Antonio, Texas 78229 United States	Status: Recruiting	Contact: Contact Daniel Zainfeld, MD 210-617-4116 [email protected] Principal Investigator Daniel Zainfeld, MD
Facility: Urology of Virginia Virginia Beach, Virginia 23462 United States	Status: Recruiting	Contact: Contact Michael Williams, MD [email protected] Principal Investigator Williams Michael, MD
Facility: Spokane Urology Spokane, Washington 99202 United States	Status: Recruiting	Contact: Contact Shane Pearce, MD 509-747-3147 [email protected] Principal Investigator Shane Pearce, MD

Brief Title: 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)

INTRODUCTION

BRIEF SUMMARY

DETAILED DESCRIPTION

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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