An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

April 13, 2026 updated by: CG Oncology, Inc.

An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

All participants will be assigned the same treatment schedule. Participants will receive an induction course of 6 weekly treatments, and, if there is no disease recurrence at Week 13, participants will receive a cycle of 3 weekly treatments up to Week 15.

If there is persistent HG Ta and/or CIS at Week 13, participants may receive a second induction cycle.

If the participant has persistent but improved HG Ta and/or CIS at Week 25 or a later timepoint, the participant may receive a cycle of 3 weekly treatments of cretostimogene at the discretion of the Investigator provided that T1 or higher stage of urothelial carcinoma is not present.

If there is no disease present at Week 25 or a later timepoint, participants will receive a cycle of 3 weekly treatments every 12 weeks through Month 12.

After Month 12, participants will receive a cycle of 3 weekly treatments every 6 months through the last treatment cycle at Month 24, or until discontinuation from the study treatment.

Disease status will be assessed based on local standard of care (which may include urine cytology, cystoscopy, and directed TURBT/biopsy) every 12 weeks. CTU/MRU can be done per standard of care evaluation at investigator's discretion.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

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

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Available
        • Banner MD Anderson Cancer Center
    • California
      • Bakersfield, California, United States, 93301
        • Available
        • Michael G. Oefelein Clinical Trials
      • Los Angeles, California, United States, 90033
        • Available
        • University of Southern California / Norris Comprehensive Cancer Center
      • Murrieta, California, United States, 92563
        • Available
        • McR, Llc.
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Available
        • Medstar Washington Hospital Center
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Available
        • Advanced Urology Institute
      • Lakeland, Florida, United States, 33805
        • Available
        • Lakeland Regional Medical Center - Hollis Cancer Center
      • Largo, Florida, United States, 33771
        • Available
        • Advanced Urology Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Available
        • Emory University
    • Illinois
      • Chicago Ridge, Illinois, United States, 60415
        • Available
        • Uropartners c/o Associated Urological Specialists
      • Glenview, Illinois, United States, 60026
        • Available
        • UroPartners, LLC
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Available
        • Urologic Specialists of Northwest Indiana
    • Iowa
      • Clive, Iowa, United States, 50325
        • Available
        • Urology Center of Iowa Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Available
        • Brigham and Women's Hospital
    • Michigan
      • Troy, Michigan, United States, 40484
        • Available
        • Michigan Institute of Urology, PC
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Available
        • Mayo Clinic Rochester
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Available
        • The Urology Group, P.C.
    • New York
      • New York, New York, United States, 10016
        • Available
        • Integrated Medical Professionals, PLLC
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Available
        • MidLantic Urology
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Available
        • Lowcountry Urology Clinics, PA
    • Texas
      • Arlington, Texas, United States, 76017
        • Available
        • Urology Partners of North Texas Research Institute
      • Dallas, Texas, United States, 75231
        • Available
        • Urology Clinics of North Texas
      • San Antonio, Texas, United States, 78229
        • Available
        • Urology San Antonio, PA dba USA Clinical Trials
      • Wichita Falls, Texas, United States, 76301
        • Available
        • Digestive Health Research of North Texas
    • Washington
      • Seattle, Washington, United States, 98195
        • Available
        • University of Washington Medical Center
      • Spokane, Washington, United States, 99202
        • Available
        • Spokane Urology

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

N/A

Description

Inclusion Criteria:

  1. Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following:

    • Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease)
    • Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 15 months of the initial qualifying dose of BCG.
  2. Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment
  3. Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
  4. Acceptable baseline organ function

Exclusion Criteria:

  1. Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.
  2. Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed.
  3. Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1
  4. Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.

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?

Collaborators and Investigators

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

Sponsor

CG Oncology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRETO-EAP

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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