Non-Muscle Invasive Bladder CancerNCT06443944
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
A study testing Cretostimogene Grenadenorepvec and n-dodecyl-B-D-maltoside in people with Non-Muscle Invasive Bladder Cancer and Urothelial Carcinoma, run by CG Oncology, Inc. at 27 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer
- What is being tested?
- Cretostimogene Grenadenorepvec and n-dodecyl-B-D-maltoside
- How many people
- Not given
- Where
- 27 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
- Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment
- Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
- Acceptable baseline organ function
Who cannot join
- Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.
- 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.
- Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1
- Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
- Available
Urology Partners of North Texas Research Institute
Arlington, Texas, 76017
Grace Yoon, grace.yoon@objective.health
Cecillia Diaz, cecillia.diaz@objective.health
- Available
Emory University
Atlanta, Georgia, 30322
Karol Cain, Karol.cain@emory.edu
Vikram Narayan, MD
- Available
Michael G. Oefelein Clinical Trials
Bakersfield, California, 93301
Evelyn De La Cruz, 661-310-1063, edelacruz@droefelein.com
Michael G Oefelein, MD
- Available
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Ashley Dziados, adziados@midlanticurology.com
Laurence Belkoff, DO
- Available
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Ramona Faris, rfaris1@bwh.harvard.edu
Mark Preston, MD
- Available
Uropartners c/o Associated Urological Specialists
Chicago Ridge, Illinois, 60415
Kevia Semmes, k.semmes@auspecialists.com
Aaron D. Berger, MD
- Available
Urology Center of Iowa Research
Clive, Iowa, 50325
Danielle Hahn, Danielle.hahn@objective.health
Brian L. Gallagher, MD
- Available
Urology Clinics of North Texas
Dallas, Texas, 75231
Alexia Demitsas, ademitsas@urologyclinics.com
Jacob Taylor, MD
- Available
Advanced Urology Institute
Daytona Beach, Florida, 32114
Seema Waris, seema.waris@auihealth.com
Samuel Lawindy
- Available
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Joseph Mashni, 206-210-4040, Joseph.Mashni@bannerhealth.com
Gabrielle Santor, Gabrielle.Santor@bannerhealth.com
- Available
UroPartners, LLC
Glenview, Illinois, 60026
Karolina Webb, kwebb@uropartners.com
Jeffrey Pearl, MD
- Available
Lakeland Regional Medical Center - Hollis Cancer Center
Lakeland, Florida, 33805
Brittany Collins, brittany.collins@mylrh.org
Dana Crowder, Dana.Crowder@myLRH.org
- Available
Advanced Urology Institute
Largo, Florida, 33771
Amy Franklin, amy.franklin@auihealth.com
Matthew Truesdale, MD
- Available
University of Southern California / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Christian Gonzalez-Gomez, 206-210-4040, Christian.GonzalezGomez@med.usc.edu
Anne Schuckman, MD
- Available
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, 46410
Shawna Clemons, sclemons@urologic-specialists.com
Manoj Rao
- Available
McR, Llc.
Murrieta, California, 92563
Laura Guerrero, 951-677-3000, Laura.guerrero@folioclinicalresearch.com
Madhumitha Reddy, DO
- Available
Integrated Medical Professionals, PLLC
New York, New York, 10016
Michael Yang, myang@imppllc.com
Jed Kaminetsky, MD
- Available
Lowcountry Urology Clinics, PA
North Charleston, South Carolina, 29406
Samara Grimes, sgrimes@lcurology.com
Justin Ellett
- Available
Urology Nevada
Reno, Nevada, 89511
Angelique Vollmer, 702-823-8965, avollmer@urologynevada.com
Dimitar Zlatev, MD
- Available
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Kathyrn Barthels, barthels.kathryn@mayo.edu
Paras Shah, MD
- Available
Urology San Antonio, PA dba USA Clinical Trials
San Antonio, Texas, 78229
Trinifer Rosario, trinifer.rosario@usa-clinicaltrials.com
Valerie Strickland, valerie.strickland@usa-clinicaltrials.com
- Available
University of Washington Medical Center
Seattle, Washington, 98195
Casey Li, 206-210-4040, cyl14@uw.edu
Sarah Psutka, MD
- Available
The Urology Group, P.C.
Southaven, Mississippi, 38671
Heer Patel, hpatel@memphisurology.com
Mark Greenberger
- Available
Spokane Urology
Spokane, Washington, 99202
Amy Bardwell, 509-747-3147 ext. 112, amyb@spokaneurology.com
Shane Pearce, MD
- Available
Michigan Institute of Urology, PC
Troy, Michigan, 40484
Danielle Osterhout, osterhoutd@michiganurology.com
Jason Hafron
- Available
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Win Phyu, win.phyu@medstar.net
Lambros Stamatakis, MD
- Available
Digestive Health Research of North Texas
Wichita Falls, Texas, 76301
Rebekah Milligan, rebekah.milligan@objective.health
Katherine E. Dowd, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Keywords
- Urology, Bladder Cancer, Non Muscle Invasive Bladder Cancer, Cretostimogene Grenadenorepvec
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Carcinoma, Transitional Cell, Urologic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cretostimogene GrenadenorepvecDrug
Also called CG0070
Engineered Oncolytic Adenovirus
n-dodecyl-B-D-maltosideOther
Also called DDM
Transduction-enhancing agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- CG Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443944
- Sponsor's protocol ID
- CRETO-EAP
- Status last verified
- Sep 2026
- First submitted
- 30 May 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
Publications
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.
PubMed 27317986Holzbeierlein 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.
PubMed 38265030
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
- ClinicalTrials.gov ID
- NCT06443944
- Acronym / sponsor ID
- CRETO-EAP
- Keywords
- Urology, Bladder Cancer, Non Muscle Invasive Bladder Cancer, Cretostimogene Grenadenorepvec
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- CG Oncology, Inc.Industry (pharma, biotech, devices)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment
- Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
- Acceptable baseline organ function
Key exclusion criteria (4 listed)
- Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.
- 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.
- Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1
- Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cretostimogene GrenadenorepvecAlso: CG0070Engineered Oncolytic Adenovirus | Drug | – |
| n-dodecyl-B-D-maltosideAlso: DDMTransduction-enhancing agent | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 27317986Chang 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.
- Background: PubMed 38265030Holzbeierlein 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.
- NCCN Guidelines Bladder Cancer 1.2025Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cretostimogene Grenadenorepvec and n-dodecyl-B-D-maltoside in people with Non-Muscle Invasive Bladder Cancer and Urothelial Carcinoma, run by CG Oncology, Inc. at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rob Svatek, MD ((949) 419-6203, recruitment@cgoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06443944, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.