RecruitingPhase 2NCT06567743

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)

Sponsor

CG Oncology, Inc.

Enrollment

325 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new bladder cancer treatment called cretostimogene grenadenorepvec (CG), which is a modified virus that targets and destroys cancer cells. It is being studied in people with high-risk, non-muscle-invasive bladder cancer (cancer that stays in the lining of the bladder), including those who have or have not previously received BCG therapy (the standard bladder cancer treatment). **You may be eligible if:** - You have been confirmed to have high-risk, high-grade bladder cancer (non-muscle-invasive) within the past 90 days - All visible tumors have been removed as much as possible - Your blood counts and organ function are within acceptable ranges - You may be in different groups: BCG-naive (never had BCG), BCG-exposed, or BCG-unresponsive **You may NOT be eligible if:** - Your bladder cancer has grown into the muscle wall (muscle-invasive) - Your cancer has spread beyond the bladder - You are unable to tolerate the study procedures - You do not meet organ function requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCretostimogene Grenadenorepvec

Respective Cohort

Locations(65)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Arizona Urology Specialty

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Arkansas Urology

Little Rock, Arkansas, United States

Michael G Oefelein, MD Clinical Trials

Bakersfield, California, United States

Genesis Research (Greater Los Angeles)

Los Alamitos, California, United States

Advanced Urology

Los Angeles, California, United States

Urology Center of Southern California

Murrieta, California, United States

University of California, Irvine

Orange, California, United States

Om research

San Diego, California, United States

University of Southern California

San Diego, California, United States

Genesis Research (Greater Los Angeles)

Torrance, California, United States

Colorado Urology

Lakewood, Colorado, United States

Urology Associates, Lone Tree

Lone Tree, Colorado, United States

University of Florida

Gainesville, Florida, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Advanced Urology Institute (Solaris)

Largo, Florida, United States

Advanced Urology Institute

Oxford, Florida, United States

Advanced Urology Institute - Tallahassee (Solaris)

Tallahassee, Florida, United States

Emory University

Atlanta, Georgia, United States

Associated Urological Specialists

Chicago Ridge, Illinois, United States

Uropartners

Glenview, Illinois, United States

Urology of Indiana - Carmel

Carmel, Indiana, United States

Urology of Indiana, LLC (US Urology Partners)

Greenwood, Indiana, United States

First Urology, PSC

Jeffersonville, Indiana, United States

Urologic Specialists of Northwest Indiana (Solaris)

Merrillville, Indiana, United States

Urology Center of Iowa Research

Clive, Iowa, United States

Wichita Urology Group

Wichita, Kansas, United States

Southern Urology (Urology America)

Lafayette, Louisiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Anne Arundel Urology

Annapolis, Maryland, United States

Chesapeake Urology Research Associates

Hanover, Maryland, United States

Comprehensive Urology

Royal Oak, Michigan, United States

Michigan Institute of Urology (Solaris)

Troy, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Minnesota Urology

Woodbury, Minnesota, United States

Specialty Clinical Research of St. Louis

St Louis, Missouri, United States

Adult and Adolescent Urology

Omaha, Nebraska, United States

Integrated Medical Professionals, PLLC (Solaris)

New York, New York, United States

University of Rochester

Rochester, New York, United States

SUNY Upstate

Syracuse, New York, United States

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

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

The Urology Group (Solaris)

Cincinnati, Ohio, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

Central Ohio Urology Group (US Urology Partners)

Gahanna, Ohio, United States

Oregon Urology Institute

Springfield, Oregon, United States

Midlantic Urology (Solaris)

Bala-Cynwyd, Pennsylvania, United States

Penn State University Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Charleston Area Medical Center

Charleston, South Carolina, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Lowcountry Urology (Solaris)

North Charleston, South Carolina, United States

The Conrad Pearson Clinic (Urology America)

Germantown, Tennessee, United States

Urology Associates, PC

Nashville, Tennessee, United States

Amarillo Urology Research

Amarillo, Texas, United States

UPNT Research Institute, LLC

Arlington, Texas, United States

Urology Austin, PLLC (Urology America)

Austin, Texas, United States

Urology Clinics of North Texas, PLLC

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist

Houston, Texas, United States

Urology San Antonio, PA dba USA Clinical Trials

San Antonio, Texas, United States

Urology of Virginia

Virginia Beach, Virginia, United States

Spokane Urology

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06567743