An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
NCT ID: NCT06443944
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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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.
Conditions
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Interventions
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Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
n-dodecyl-B-D-maltoside
Transduction-enhancing agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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CG Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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Michael G. Oefelein Clinical Trials
Bakersfield, California, United States
McR, Llc.
Murrieta, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
Advanced Urology Institute
Largo, Florida, United States
Emory University
Atlanta, Georgia, United States
Uropartners c/o Associated Urological Specialists
Chicago Ridge, Illinois, United States
UroPartners, LLC
Glenview, Illinois, United States
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, United States
Urology Center of Iowa Research
Clive, Iowa, United States
Michigan Institute of Urology, PC
Troy, Michigan, United States
The Urology Group, P.C.
Southaven, Mississippi, United States
Integrated Medical Professionals, PLLC
New York, New York, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Lowcountry Urology Clinics, PA
North Charleston, South Carolina, United States
Urology Partners of North Texas Research Institute
Arlington, Texas, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Urology San Antonio, PA dba USA Clinical Trials
San Antonio, Texas, United States
Digestive Health Research of North Texas
Wichita Falls, Texas, United States
Spokane Urology
Spokane, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16.
Holzbeierlein JM, Bixler BR, Buckley DI, Chang SS, Holmes R, James AC, Kirkby E, McKiernan JM, Schuckman AK. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment. J Urol. 2024 Apr;211(4):533-538. doi: 10.1097/JU.0000000000003846. Epub 2024 Jan 24.
Related Links
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NCCN Guidelines Bladder Cancer 1.2025
Other Identifiers
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CRETO-EAP
Identifier Type: -
Identifier Source: org_study_id