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Bladder cancer virus therapy shows promise in Mid-Stage trial

NCT ID NCT06567743

Disease control Sponsor: CG Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This Phase 2 trial tests a drug called cretostimogene grenadenorepvec in 325 people with high-risk non-muscle-invasive bladder cancer. The drug is a virus that is put directly into the bladder to attack cancer cells. The study looks at how well it works and how safe it is, including when used alone or with another drug called gemcitabine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cretostimogene grenadenorepvec (a virus-based therapy given directly into the bladder)
What this could lead to
If successful, this could offer a new treatment option for high-risk bladder cancer that avoids or delays bladder removal surgery.
What could go wrong
This is a Phase 2 trial, so it's still early. The therapy may not work for everyone, and side effects from the virus or combination with other drugs are possible.
Why investors are watching

CG Oncology is testing cretostimogene grenadenorepvec, an experimental therapy for high-risk non-muscle-invasive bladder cancer, in a Phase 2 study with 325 participants. For a small company, this readout is a major test of whether its lead drug works and is safe enough to advance, which could shape the company's future value.

If it works: If the trial shows the drug controls the disease with an acceptable safety profile, CG Oncology could move closer to seeking regulatory approval and building a commercial product. A positive result may also attract larger partners or funding to support further development.

If it fails: The trial could fail to show enough benefit or reveal safety problems, which would likely stall the drug's progress and hurt the company's prospects. Many Phase 2 trials do not succeed, so a negative outcome is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 325 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

superficial urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High-risk non-muscle-invasive bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    76 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accellacare

    RECRUITING

    Lisle, Illinois, 60532, United States

  • Adult and Adolescent Urology

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Advanced Urology

    WITHDRAWN

    Los Angeles, California, 90045, United States

  • Advanced Urology Institute

    RECRUITING

    Oxford, Florida, 34484, United States

  • Advanced Urology Institute (Solaris)

    RECRUITING

    Largo, Florida, 33771, United States

  • Advanced Urology Institute - Tallahassee (Solaris)

    WITHDRAWN

    Tallahassee, Florida, 32308, United States

  • Amarillo Urology Research

    COMPLETED

    Amarillo, Texas, 79106, United States

  • Anne Arundel Urology

    RECRUITING

    Annapolis, Maryland, 21401, United States

  • Arizona Urology Specialty

    WITHDRAWN

    Tucson, Arizona, 85704, United States

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

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

    RECRUITING

    Syracuse, New York, 13210, United States

  • Associated Urological Specialists

    RECRUITING

    Chicago Ridge, Illinois, 60415, United States

  • Associated Urologist of North Carolina (Solaris)

    RECRUITING

    Raleigh, North Carolina, 27612, United States

  • Atrium Health/Levine Center

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Carolina Urologic Research Center, LLC

    RECRUITING

    Myrtle Beach, South Carolina, 229572, United States

  • Central Ohio Urology Group (US Urology Partners)

    RECRUITING

    Gahanna, Ohio, 43230, United States

  • Centre of Applied Urology Research Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Charleston Area Medical Center

    RECRUITING

    Charleston, South Carolina, 25304, United States

  • Chesapeake Urology Research Associates

    RECRUITING

    Hanover, Maryland, 21076, United States

  • City of Hope

    RECRUITING

    Irvine, California, 92518, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Colorado Urology

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • Comprehensive Urology

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • First Urology, PSC

    RECRUITING

    Jeffersonville, Indiana, 47130, United States

  • Genesis Research (Greater Los Angeles)

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Genesis Research (Greater Los Angeles)

    RECRUITING

    Torrance, California, 90503, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • Integrated Medical Professionals, PLLC (Solaris)

    RECRUITING

    New York, New York, 10016, United States

  • Keystone Urology Specialists

    RECRUITING

    Lancaster, Pennsylvania, 17604, United States

  • Lowcountry Urology (Solaris)

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Michael G Oefelein, MD Clinical Trials

    RECRUITING

    Bakersfield, California, 93301, United States

  • Michigan Institute of Urology (Solaris)

    RECRUITING

    Troy, Michigan, 48084, United States

  • Midlantic Urology (Solaris)

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Minnesota Urology

    RECRUITING

    Woodbury, Minnesota, 55123, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Ochsner Medical Center

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Om research

    RECRUITING

    San Diego, California, 91223, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Oregon Urology Institute

    RECRUITING

    Springfield, Oregon, 97447, United States

  • Penn State University Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Portland VA

    RECRUITING

    Portland, Oregon, 97239, United States

  • Potomac Urology

    RECRUITING

    Alexandria, Virginia, 22311, United States

  • SUNY Upstate

    RECRUITING

    Syracuse, New York, 13202, United States

  • Southern Urology (Urology America)

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • Specialty Clinical Research of St. Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Spokane Urology

    RECRUITING

    Spokane, Washington, 99202, United States

  • The Conrad Pearson Clinic (Urology America)

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • The Urology Group (Solaris)

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • UC Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • UPNT Research Institute, LLC

    RECRUITING

    Arlington, Texas, 76017, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California, Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of Cincinnati Cancer Center

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32611, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14620, United States

  • University of Southern California

    RECRUITING

    San Diego, California, 92123, United States

  • Urologic Specialists of Northwest Indiana (Solaris)

    RECRUITING

    Merrillville, Indiana, 46410, United States

  • Urology Associates, Lone Tree

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • Urology Associates, PC

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Urology Austin, PLLC (Urology America)

    RECRUITING

    Austin, Texas, 78745, United States

  • Urology Center of Iowa Research

    RECRUITING

    Clive, Iowa, 50325, United States

  • Urology Center of Southern California

    RECRUITING

    Murrieta, California, 92563, United States

  • Urology Clinics of North Texas, PLLC

    RECRUITING

    Dallas, Texas, 75231, United States

  • Urology San Antonio, PA dba USA Clinical Trials

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Urology of Indiana - Carmel

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Urology of Indiana, LLC (US Urology Partners)

    RECRUITING

    Greenwood, Indiana, 46143, United States

  • Urology of Virginia

    RECRUITING

    Virginia Beach, Virginia, 23462, United States

  • Uropartners

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Wichita Urology Group

    RECRUITING

    Wichita, Kansas, 67226, United States

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Other studies related to the condition(s) this trial covers.