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

April 6, 2026 updated by: CG Oncology, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

325

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona
        • Principal Investigator:
          • Mark Tyson, MD
        • Contact:
      • Tucson, Arizona, United States, 85704
        • Withdrawn
        • Arizona Urology Specialty
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
        • Principal Investigator:
          • Ahmet Aydin, MD
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Arkansas Urology
        • Contact:
        • Principal Investigator:
          • Jon Henderson, MD
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Michael G Oefelein, MD Clinical Trials
        • Principal Investigator:
          • Michael G Oefelein, MD
        • Contact:
          • Michael G Oefelein, MD
          • Phone Number: 661-310-1063
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Genesis Research (Greater Los Angeles)
        • Contact:
        • Principal Investigator:
          • Sepehr Nowfar, MD
      • Los Angeles, California, United States, 90045
        • Withdrawn
        • Advanced Urology
      • Murrieta, California, United States, 92563
        • Recruiting
        • Urology Center of Southern California
        • Contact:
        • Principal Investigator:
          • Madhumitha Reddy, MD
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Edward Uchio, MD
        • Contact:
      • San Diego, California, United States, 91223
        • Recruiting
        • Om Research
        • Principal Investigator:
          • Paul Dato, MD
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • Siamek Daneshmand, MD
      • Torrance, California, United States, 90503
        • Recruiting
        • Genesis Research (Greater Los Angeles)
        • Contact:
        • Principal Investigator:
          • Timothy Lesser, MD
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Colorado Urology
        • Principal Investigator:
          • David Cahn, MD
        • Contact:
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Urology Associates, Lone Tree
        • Contact:
        • Principal Investigator:
          • Daniel Mazur, MD
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Padaric O'Malley, MD
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Contact:
        • Principal Investigator:
          • Andrew Zganjar, MD
      • Largo, Florida, United States, 33771
        • Recruiting
        • Advanced Urology Institute (Solaris)
        • Principal Investigator:
          • Matthew Truesdale, MD
        • Contact:
      • Oxford, Florida, United States, 34484
        • Recruiting
        • Advanced Urology Institute
        • Contact:
        • Principal Investigator:
          • Edward King, MD
      • Tallahassee, Florida, United States, 32308
        • Withdrawn
        • Advanced Urology Institute - Tallahassee (Solaris)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Shreyas Joshi, MD
        • Contact:
    • Illinois
      • Chicago Ridge, Illinois, United States, 60415
        • Recruiting
        • Associated Urological Specialists
        • Principal Investigator:
          • Aaron Berger, MD
        • Contact:
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • UroPartners
        • Contact:
        • Principal Investigator:
          • Jeffrey Pearl, MD
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Urology of Indiana - Carmel
        • Principal Investigator:
          • Chad Reichard, MD
        • Contact:
      • Greenwood, Indiana, United States, 46143
        • Recruiting
        • Urology of Indiana, LLC (US Urology Partners)
        • Principal Investigator:
          • Eugene Cone, MD
        • Contact:
      • Jeffersonville, Indiana, United States, 47130
        • Recruiting
        • First Urology, PSC
        • Principal Investigator:
          • Ryan Malone, MD
        • Contact:
      • Merrillville, Indiana, United States, 46410
        • Recruiting
        • Urologic Specialists of Northwest Indiana (Solaris)
        • Principal Investigator:
          • Manoj Rao, MD
        • Contact:
    • Iowa
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Urology Center of Iowa Research
        • Principal Investigator:
          • Brian Gallagher, MD
        • Contact:
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Wichita Urology Group
        • Principal Investigator:
          • Philippe Nabbout, MD
        • Contact:
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Southern Urology (Urology America)
        • Principal Investigator:
          • Jason Bourque, MD
        • Contact:
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center
        • Contact:
        • Principal Investigator:
          • Kyle Rose, MD
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Anne Arundel Urology
        • Contact:
        • Principal Investigator:
          • Mara Holton, MD
      • Hanover, Maryland, United States, 21076
        • Recruiting
        • Chesapeake Urology Research Associates
        • Principal Investigator:
          • Rian Dickstein, MD
        • Contact:
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Comprehensive Urology
        • Principal Investigator:
          • Adam Gadzinski, MD
        • Contact:
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Michigan Institute of Urology (Solaris)
        • Principal Investigator:
          • Jason Hafron, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Principal Investigator:
          • Paras Shah, MD
        • Contact:
      • Woodbury, Minnesota, United States, 55123
        • Recruiting
        • Minnesota Urology
        • Principal Investigator:
          • Aaron Milbank, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Specialty Clinical Research of St. Louis
        • Principal Investigator:
          • Gregory Auffenberg, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Adult and Adolescent Urology
        • Principal Investigator:
          • Andrew Trainer, MD
        • Contact:
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Integrated Medical Professionals, PLLC (Solaris)
        • Principal Investigator:
          • Jed Kaminetsky, MD
        • Contact:
      • Rochester, New York, United States, 14620
      • Syracuse, New York, United States, 13202
        • Recruiting
        • SUNY Upstate
        • Contact:
        • Principal Investigator:
          • Joseph Jacob, MD
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Associated Medical Professionals of NY, PLLC (US Urology Partners)
        • Principal Investigator:
          • Christopher Pieczonka, MD
        • Contact:
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Alexander Sankin, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Cancer Center
        • Contact:
        • Principal Investigator:
          • Alberto Martini, MD
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • The Urology Group (Solaris)
        • Contact:
        • Principal Investigator:
          • Marc Pliskin, MD
      • Gahanna, Ohio, United States, 43230
        • Recruiting
        • Central Ohio Urology Group (US Urology Partners)
        • Contact:
        • Principal Investigator:
          • Benjamin Martin, MD
    • Oregon
      • Springfield, Oregon, United States, 97447
        • Recruiting
        • Oregon Urology Institute
        • Principal Investigator:
          • Bryan Mehlhaff, MD
        • Contact:
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • Midlantic Urology (Solaris)
        • Principal Investigator:
          • Laurence Belkoff, MD
        • Contact:
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State University Milton S. Hershey Medical Center
        • Principal Investigator:
          • Jay Raman, MD
        • Contact:
      • Lancaster, Pennsylvania, United States, 17604
        • Recruiting
        • Keystone Urology Specialists
        • Principal Investigator:
          • Paul Sieber, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Charleston, South Carolina, United States, 25304
        • Recruiting
        • Charleston Area Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Stencel, MD
      • Myrtle Beach, South Carolina, United States, 229572
        • Recruiting
        • Carolina Urologic Research Center, LLC
        • Contact:
        • Principal Investigator:
          • Neal Shore, MD
      • North Charleston, South Carolina, United States, 29406
        • Recruiting
        • Lowcountry Urology (Solaris)
        • Principal Investigator:
          • Justin Ellett, MD
        • Contact:
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The Conrad Pearson Clinic (Urology America)
        • Contact:
        • Principal Investigator:
          • Michael Granieri, MD
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates, PC
        • Principal Investigator:
          • Gautam Jayram, MD
        • Contact:
    • Texas
      • Amarillo, Texas, United States, 79106
        • Completed
        • Amarillo Urology Research
      • Arlington, Texas, United States, 76017
        • Recruiting
        • UPNT Research Institute, LLC
        • Principal Investigator:
          • Michael Collini, MD
        • Contact:
      • Austin, Texas, United States, 78745
        • Recruiting
        • Urology Austin, PLLC (Urology America)
        • Contact:
        • Principal Investigator:
          • Brian Mazzarella
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Principal Investigator:
          • Solomon Woldu, MD
        • Contact:
          • Catherine Rodriguez
          • Phone Number: 214-645-8787
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Urology Clinics of North Texas, PLLC
        • Contact:
        • Principal Investigator:
          • Jacob Taylor, MD
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Urology San Antonio, PA dba USA Clinical Trials
        • Principal Investigator:
          • Daniel Zainfeld, MD
        • Contact:
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Urology of Virginia
        • Contact:
        • Principal Investigator:
          • Williams Michael, MD
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Spokane Urology
        • Principal Investigator:
          • Shane Pearce, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Cohort A, Arm 1
Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method
Drug: Cretostimogene Grenadenorepvec
Respective Cohort
Other Names:
  • CG0070
Experimental: Experimental: Cohort A, Arm 2
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Drug: Cretostimogene Grenadenorepvec
Respective Cohort
Other Names:
  • CG0070
Experimental: Experimental: Cohort B, Arm 1
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Drug: Cretostimogene Grenadenorepvec
Respective Cohort
Other Names:
  • CG0070
Experimental: Experimental: Cohort B, Arm 2
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Drug: Cretostimogene Grenadenorepvec
Respective Cohort
Other Names:
  • CG0070
Experimental: Experimental: Cohort A, Arm 3
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Drug: Cretostimogene Grenadenorepvec
Respective Cohort
Other Names:
  • CG0070
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
Drug: Cretostimogene Grenadenorepvec
Respective Cohort
Other Names:
  • CG0070
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
Drug: Cretostimogene Grenadenorepvec
Respective Cohort
Other Names:
  • CG0070

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort A (Arm 1 and 2): Complete response rate
Time Frame: 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
At 11 and 24 weeks
Cohort A (Arm 3): High- Grade Event-Free Survival
Time Frame: 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.
48 months
Cohort B (Arm 1): Complete response rate
Time Frame: 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.
At 11 and 24 weeks
Cohort B (Arm 2): High-Grade Event-Free Survival
Time Frame: 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.
48 months
Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival
Time Frame: 48 months
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.
48 months
Cohort CX (Arms 1 and 2): Safety
Time Frame: 48 months
Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort A (Arms 1 and 2): Evaluate cretostimogene instillation methods
Time Frame: At 11 and 24 weeks
Evaluate cretostimogene genome and GM-CSF levels, treatment efficacy, and safety by 2 different methods of cretostimogene instillation in participants with pathologically confirmed CIS-containing high-risk NMIBC who are naïve to BCG treatment.
At 11 and 24 weeks
Cohort A (Arm 3): High-Grade Event-Free Survival at 12 months
Time Frame: At 12 months
Determine the proportion of participants with BCG-naive papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months
At 12 months
Cohort A (Arms 1 and 2) and Cohort B (Arm 1) Duration of response
Time Frame: 48 months
Assess duration of response in participants with CIS with or without concomitant HG Ta/T1 disease at baseline
48 months
Cohort B (Arm 2) High-Grade Event-Free Survival at 12 months
Time Frame: At 12 months
Determine the proportion of participants with BCG-exposed papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months
At 12 months
Cohort CX (Arm 1 and 2) Complete response rate
Time Frame: At 11 and 24 weeks
Determine the complete response rate at any time following treatment with cretostimogene and gemcitabine in participants with BCG-exposed or BCG-unresponsive CIS with or without concomitant high-grade Ta or T1 disease at baseline.
At 11 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CG Oncology, Inc.

Investigators

  • Study Director: Vijay Kasturi, MD, CG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORE-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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