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

NCT06567743 · tracked via the Priya Life Science USA tracker

Sponsor

CG Oncology, Inc.

Phase

Phase 2

Started

2024-09-16

Last updated

2026-09-03

Condition(s) studied

High-Risk Non-Muscle-Invasive Bladder Cancer

Investigational drug(s) / intervention(s)

Cretostimogene Grenadenorepvec →

Cretostimogene Grenadenorepvec: Respective Cohort

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Cohort A (Arm 1 and 2): Complete response rate — At 11 and 24 weeks
Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-naïve CIS with or without concomitant high-grade Ta or T1 disease at baseline
Cohort A (Arm 3): High- Grade Event-Free Survival — 48 months
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-naïve HG Ta/T1 disease without concomitant CIS at baseline.
Cohort B (Arm 1): Complete response rate — At 11 and 24 weeks
Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-exposed CIS with or without concomitant high-grade Ta or T1 disease at baseline.
Cohort B (Arm 2): High-Grade Event-Free Survival — 48 months
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed high-grade Ta/T1 papillary disease without CIS at baseline.
Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival — 48 months
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.
Cohort CX (Arms 1 and 2): Safety — 48 months
Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.

Trial sites (80)

Facility	City	Region	Status
Banner MD Anderson Cancer Center	Gilbert	Arizona	Recruiting
Mayo Clinic Arizona	Phoenix	Arizona	Recruiting
Arizona Urology Specialty	Tucson	Arizona	Withdrawn
University of Arkansas for Medical Sciences	Little Rock	Arkansas	Recruiting
Arkansas Urology	Little Rock	Arkansas	Recruiting
Michael G Oefelein, MD Clinical Trials	Bakersfield	California	Recruiting
City of Hope	Irvine	California	Recruiting
Genesis Research (Greater Los Angeles)	Los Alamitos	California	Recruiting
Advanced Urology	Los Angeles	California	Withdrawn
Urology Center of Southern California	Murrieta	California	Recruiting
University of California, Irvine	Orange	California	Recruiting
UC Davis	Sacramento	California	Recruiting
Om research	San Diego	California	Recruiting
University of Southern California	San Diego	California	Recruiting
Genesis Research (Greater Los Angeles)	Torrance	California	Recruiting
Colorado Urology	Lakewood	Colorado	Recruiting
Urology Associates, Lone Tree	Lone Tree	Colorado	Recruiting
University of Florida	Gainesville	Florida	Recruiting
Mayo Clinic Florida	Jacksonville	Florida	Recruiting
Advanced Urology Institute (Solaris)	Largo	Florida	Recruiting
Advanced Urology Institute	Oxford	Florida	Recruiting
Advanced Urology Institute - Tallahassee (Solaris)	Tallahassee	Florida	Withdrawn
Emory University	Atlanta	Georgia	Recruiting
Associated Urological Specialists	Chicago Ridge	Illinois	Recruiting
Uropartners	Glenview	Illinois	Recruiting
Accellacare	Lisle	Illinois	Recruiting
Urology of Indiana - Carmel	Carmel	Indiana	Recruiting
Urology of Indiana, LLC (US Urology Partners)	Greenwood	Indiana	Recruiting
First Urology, PSC	Jeffersonville	Indiana	Recruiting
Urologic Specialists of Northwest Indiana (Solaris)	Merrillville	Indiana	Recruiting
Urology Center of Iowa Research	Clive	Iowa	Recruiting
Wichita Urology Group	Wichita	Kansas	Recruiting
Southern Urology (Urology America)	Lafayette	Louisiana	Recruiting
Ochsner Medical Center	New Orleans	Louisiana	Recruiting
Anne Arundel Urology	Annapolis	Maryland	Recruiting
Chesapeake Urology Research Associates	Hanover	Maryland	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Comprehensive Urology	Royal Oak	Michigan	Recruiting
Michigan Institute of Urology (Solaris)	Troy	Michigan	Recruiting
Mayo Clinic Rochester	Rochester	Minnesota	Recruiting

+ 40 more sites — see the full list on the official registry below.

More CG Oncology, Inc. trials in the USA

A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT Active, not recruiting

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06567743 on ClinicalTrials.gov ↗ ← All trials in the USA