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

September 1, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
325

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • Centre of Applied Urology Research Nova Scotia Health Authority
        • Principal Investigator:
          • Ricardo Rendon, MD
        • Contact:
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Principal Investigator:
          • Chinedu Mmeje, MD
        • Contact:
      • 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
      • Irvine, California, United States, 92518
        • Recruiting
        • City Of Hope
        • Contact:
        • Principal Investigator:
          • Cory Hugen, MD
      • 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:
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis
        • Principal Investigator:
          • Thenappan Chandrasekar, 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
      • Lisle, Illinois, United States, 60532
        • Recruiting
        • Accellacare
        • Principal Investigator:
          • Ranko Miocinovic, MD
        • Contact:
    • 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:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Mark Preston, 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 Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Nitin Yerram, 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:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • Mary Westerman, MD
        • Contact:
          • Mary Westerman, MD
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health/Levine Center
        • Contact:
        • Principal Investigator:
          • Justin Matulay, MD
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Associated Urologist of North Carolina (Solaris)
        • Principal Investigator:
          • Mark Jalkut, 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
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Laura Bukavina, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Deb Sundi, MD
      • Gahanna, Ohio, United States, 43230
        • Recruiting
        • Central Ohio Urology Group (US Urology Partners)
        • Contact:
        • Principal Investigator:
          • Benjamin Martin, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Jen-Jane Lui, MD
          • Phone Number: 503-346-0640
          • Email: jenj@ohsu.edu
        • Principal Investigator:
          • Jen-Jabe Lui, ND
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Portland VA
        • Contact:
          • Nicholas Chakiryan, MD
        • Principal Investigator:
          • Nicholas Chakiryan, MD
      • 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
        • Contact:
        • Principal Investigator:
          • Kenneth Lessans, MD
      • 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
        • Recruiting
        • Houston Methodist
        • Principal Investigator:
          • Dharam Kaushik, MD
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Urology San Antonio, PA dba USA Clinical Trials
        • Principal Investigator:
          • Daniel Zainfeld, MD
        • Contact:
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Recruiting
        • Potomac Urology
        • Principal Investigator:
          • Aseem Malhotra, MD
        • Contact:
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CG Oncology, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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