Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06567743

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

Led by CG Oncology, Inc. · Updated on 2026-04-08

325

Participants Needed

65

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with pathologically confirmed high-risk high-grade non-muscle-invasive bladder cancer (NMIBC) within 90 days of treatment allocation
  • Cohort A: BCG-na�ve NMIBC (CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS)
  • Cohort B: BCG-exposed NMIBC (CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS)
  • Cohort CX: BCG-unresponsive or BCG-exposed NMIBC (CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS)
  • All visible bladder cancer must be resected and CIS resected or treated within 90 days prior to treatment allocation
  • Acceptable baseline organ function
Not Eligible

You will not qualify if you...

  • History or current diagnosis of muscle-invasive, locally advanced, or metastatic bladder cancer
  • High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months
  • T2 upper tract disease within 48 months
  • Any history of locally advanced, nodal, or metastatic disease in the upper urinary tract
  • Significant immunodeficiency
  • Pregnant or breastfeeding
  • Cohort CX only: prior serial intravesical gemcitabine within 24 months

AI-Screening

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Trial Site Locations

Total: 65 locations

1

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Arizona Urology Specialty

Tucson, Arizona, United States, 85704

Withdrawn

3

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

4

Arkansas Urology

Little Rock, Arkansas, United States, 72211

Actively Recruiting

5

Michael G Oefelein, MD Clinical Trials

Bakersfield, California, United States, 93301

Actively Recruiting

6

Genesis Research (Greater Los Angeles)

Los Alamitos, California, United States, 90720

Actively Recruiting

7

Advanced Urology

Los Angeles, California, United States, 90045

Withdrawn

8

Urology Center of Southern California

Murrieta, California, United States, 92563

Actively Recruiting

9

University of California, Irvine

Orange, California, United States, 92868

Actively Recruiting

10

Om research

San Diego, California, United States, 91223

Actively Recruiting

11

University of Southern California

San Diego, California, United States, 92123

Actively Recruiting

12

Genesis Research (Greater Los Angeles)

Torrance, California, United States, 90503

Actively Recruiting

13

Colorado Urology

Lakewood, Colorado, United States, 80228

Actively Recruiting

14

Urology Associates, Lone Tree

Lone Tree, Colorado, United States, 80124

Actively Recruiting

15

University of Florida

Gainesville, Florida, United States, 32611

Actively Recruiting

16

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

17

Advanced Urology Institute (Solaris)

Largo, Florida, United States, 33771

Actively Recruiting

18

Advanced Urology Institute

Oxford, Florida, United States, 34484

Actively Recruiting

19

Advanced Urology Institute - Tallahassee (Solaris)

Tallahassee, Florida, United States, 32308

Withdrawn

20

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

21

Associated Urological Specialists

Chicago Ridge, Illinois, United States, 60415

Actively Recruiting

22

Uropartners

Glenview, Illinois, United States, 60026

Actively Recruiting

23

Urology of Indiana - Carmel

Carmel, Indiana, United States, 46032

Actively Recruiting

24

Urology of Indiana, LLC (US Urology Partners)

Greenwood, Indiana, United States, 46143

Actively Recruiting

25

First Urology, PSC

Jeffersonville, Indiana, United States, 47130

Actively Recruiting

26

Urologic Specialists of Northwest Indiana (Solaris)

Merrillville, Indiana, United States, 46410

Actively Recruiting

27

Urology Center of Iowa Research

Clive, Iowa, United States, 50325

Actively Recruiting

28

Wichita Urology Group

Wichita, Kansas, United States, 67226

Actively Recruiting

29

Southern Urology (Urology America)

Lafayette, Louisiana, United States, 70508

Actively Recruiting

30

Ochsner Medical Center

New Orleans, Louisiana, United States, 70121

Actively Recruiting

31

Anne Arundel Urology

Annapolis, Maryland, United States, 21401

Actively Recruiting

32

Chesapeake Urology Research Associates

Hanover, Maryland, United States, 21076

Actively Recruiting

33

Comprehensive Urology

Royal Oak, Michigan, United States, 48073

Actively Recruiting

34

Michigan Institute of Urology (Solaris)

Troy, Michigan, United States, 48084

Actively Recruiting

35

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

36

Minnesota Urology

Woodbury, Minnesota, United States, 55123

Actively Recruiting

37

Specialty Clinical Research of St. Louis

St Louis, Missouri, United States, 63141

Actively Recruiting

38

Adult and Adolescent Urology

Omaha, Nebraska, United States, 68114

Actively Recruiting

39

Integrated Medical Professionals, PLLC (Solaris)

New York, New York, United States, 10016

Actively Recruiting

40

University of Rochester

Rochester, New York, United States, 14620

Actively Recruiting

41

SUNY Upstate

Syracuse, New York, United States, 13202

Actively Recruiting

42

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

Syracuse, New York, United States, 13210

Actively Recruiting

43

Montefiore Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

44

The Urology Group (Solaris)

Cincinnati, Ohio, United States, 45212

Actively Recruiting

45

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States, 45267

Actively Recruiting

46

Central Ohio Urology Group (US Urology Partners)

Gahanna, Ohio, United States, 43230

Actively Recruiting

47

Oregon Urology Institute

Springfield, Oregon, United States, 97447

Actively Recruiting

48

Midlantic Urology (Solaris)

Bala-Cynwyd, Pennsylvania, United States, 19004

Actively Recruiting

49

Penn State University Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

50

Keystone Urology Specialists

Lancaster, Pennsylvania, United States, 17604

Actively Recruiting

51

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

52

Charleston Area Medical Center

Charleston, South Carolina, United States, 25304

Actively Recruiting

53

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States, 229572

Actively Recruiting

54

Lowcountry Urology (Solaris)

North Charleston, South Carolina, United States, 29406

Actively Recruiting

55

The Conrad Pearson Clinic (Urology America)

Germantown, Tennessee, United States, 38138

Actively Recruiting

56

Urology Associates, PC

Nashville, Tennessee, United States, 37209

Actively Recruiting

57

Amarillo Urology Research

Amarillo, Texas, United States, 79106

Completed

58

UPNT Research Institute, LLC

Arlington, Texas, United States, 76017

Actively Recruiting

59

Urology Austin, PLLC (Urology America)

Austin, Texas, United States, 78745

Actively Recruiting

60

Urology Clinics of North Texas, PLLC

Dallas, Texas, United States, 75231

Actively Recruiting

61

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

62

Houston Methodist

Houston, Texas, United States, 77030

Actively Recruiting

63

Urology San Antonio, PA dba USA Clinical Trials

San Antonio, Texas, United States, 78229

Actively Recruiting

64

Urology of Virginia

Virginia Beach, Virginia, United States, 23462

Actively Recruiting

65

Spokane Urology

Spokane, Washington, United States, 99202

Actively Recruiting

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Research Team

R

Rebecca Tregunna, MD

CONTACT

P

Pat Keegan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

7

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