AzTrials
AzTrials

High-Risk Non-Muscle-Invasive Bladder CancerPhase 2NCT06567743

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

A Phase 2 study testing Cretostimogene Grenadenorepvec in people with High-Risk Non-Muscle-Invasive Bladder Cancer, run by CG Oncology, Inc. at 80 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cretostimogene Grenadenorepvec
Could I receive a placebo?
No, everyone receives an active treatment
How many people
325 participants
Where
80 sitesin 2 countries
Study dates
16 Sep 2024to 30 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

80 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Rebecca Tregunna, MD contact

949 409-3700

Rebecca.Tregunna@cgoncology.com

Pat Keegan, MD contact

949 409-3700

pat.keegan@cgoncology.com

80 sites in 2 countries

United States79 sites, 75 recruiting

  • Potomac Urology

    Alexandria, Virginia, 22311

    Aseem Malhotra, MD, 703-680-2111, amalhotra@potomacurology.com

    Aseem Malhotra, MD

    Recruiting

  • Amarillo Urology Research

    Amarillo, Texas, 79106

    Completed

  • Anne Arundel Urology

    Annapolis, Maryland, 21401

    Megan Lormore, 410-266-8049 ext. 139, mlormore@aaurology.com

    Mara Holton, MD

    Recruiting

  • UPNT Research Institute, LLC

    Arlington, Texas, 76017

    Michael Collini, MD, 682-205-8396, michael.collini@objective.health

    Michael Collini, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Shreyas Joshi, MD, shreyas.joshi@emory.edu

    Shreyas Joshi, MD

    Recruiting

  • Urology Austin, PLLC (Urology America)

    Austin, Texas, 78745

    Brian Mazzarella, MD, 512-410-3773, brian.mazzarella@urologyaustin.com

    Brian Mazzarella

    Recruiting

  • Michael G Oefelein, MD Clinical Trials

    Bakersfield, California, 93301

    Michael G Oefelein, MD, 661-310-1063

    Michael G Oefelein, MD

    Recruiting

  • Midlantic Urology (Solaris)

    Bala-Cynwyd, Pennsylvania, 19004

    Laurence Belkoff, MD, lbelkoff@midlanticurology.com

    Laurence Belkoff, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Mark Preston, MD, 617-525-8274, MPRESTON@BWH.HARVARD.EDU

    Mark Preston, MD

    Recruiting

  • Urology of Indiana - Carmel

    Carmel, Indiana, 46032

    Chad Reichard, MD, creichard@urologyin.com

    Chad Reichard, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Mary Westerman, MD

    Mary Westerman, MD

    Recruiting

  • Charleston Area Medical Center

    Charleston, South Carolina, 25304

    Michael Stencel, MD, Michael.stenceldo@gmail.com

    Michael Stencel, MD

    Recruiting

  • Atrium Health/Levine Center

    Charlotte, North Carolina, 28204

    Justin Matulay, MD, 980-442-2000, Justin.Matulay@atriumhealth.org

    Justin Matulay, MD

    Recruiting

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415

    Aaron Berger, MD, a.berger@auspecialists.com

    Aaron Berger, MD

    Recruiting

  • The Urology Group (Solaris)

    Cincinnati, Ohio, 45212

    Marc Pliskin, MD, mpliskin@urologygroup.com

    Marc Pliskin, MD

    Recruiting

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45267

    Alberto Martini, MD, 651-999-6800, marti9a7@ucmail.uc.edu

    Alberto Martini, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Laura Bukavina, MD, 216-444-2200, bukavil2@ccf.org

    Laura Bukavina, MD

    Recruiting

  • Urology Center of Iowa Research

    Clive, Iowa, 50325

    Brian Gallagher, MD, 515-992-7718, brian.gallagher@objective.health

    Brian Gallagher, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Deb Sundi, MD, 614-685-4263, D.Sundi@osumc.edu

    Deb Sundi, MD

    Recruiting

  • Urology Clinics of North Texas, PLLC

    Dallas, Texas, 75231

    Jacob Taylor, MD, 214-556-8337, jtaylor@urologyclinics.com

    Jacob Taylor, MD

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Catherine Rodriguez, 214-645-8787

    Solomon Woldu, MD

    Recruiting

  • Central Ohio Urology Group (US Urology Partners)

    Gahanna, Ohio, 43230

    Benjamin Martin, MD, 614-396-2684, bmartin@centralohiourology.com

    Benjamin Martin, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32611

    Paul Crispen, 352-273-8236, Paul.Crispen@urology.ufl.edu

    Padaric O'Malley, MD

    Recruiting

  • The Conrad Pearson Clinic (Urology America)

    Germantown, Tennessee, 38138

    Michael Granieri, MD, 901-236-0957, mgranieri@conradpearson.com

    Michael Granieri, MD

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Chinedu Mmeje, MD, 480-256-6444, Chinedu.Mmeje@bannerhealth.com

    Chinedu Mmeje, MD

    Recruiting

  • Uropartners

    Glenview, Illinois, 60026

    Jeffrey Pearl, MD, JPearl@uropartners.com;

    Jeffrey Pearl, MD

    Recruiting

  • Urology of Indiana, LLC (US Urology Partners)

    Greenwood, Indiana, 46143

    Eugene Cone, MD, 317-564-5573, econe@urologyin.com

    Eugene Cone, MD

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Nitin Yerram, MD, 551-996-8090, nitin.yerram@hmhn.org

    Nitin Yerram, MD

    Recruiting

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076

    Rian Dickstein, MD, rdcura@chesuro.com

    Rian Dickstein, MD

    Recruiting

  • Penn State University Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Susan Godfrey, 717-531-4472, sgodfrey@pennstatehealth.psu.edu

    Jay Raman, MD

    Recruiting

  • Houston Methodist

    Houston, Texas, 77030

    Dharam Kaushik, MD, kaushik@uthscsa.edu

    Dharam Kaushik, MD

    Recruiting

  • City of Hope

    Irvine, California, 92518

    Cory Hugen, MD, 949-671-4673, chugen@coh.org

    Cory Hugen, MD

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Andrew Zganjar, MD, Zganjar.Andrew@mayo.edu

    Andrew Zganjar, MD

    Recruiting

  • First Urology, PSC

    Jeffersonville, Indiana, 47130

    Ryan Malone, MD, 812-206-8164, rmalone@1sturology.com

    Ryan Malone, MD

    Recruiting

  • Southern Urology (Urology America)

    Lafayette, Louisiana, 70508

    Jason Bourque, MD, 337-422-3738, jasonbourque@gmail.com

    Jason Bourque, MD

    Recruiting

  • Colorado Urology

    Lakewood, Colorado, 80228

    David Cahn, MD, Dcahn@coloradouro.com

    David Cahn, MD

    Recruiting

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

    Kenneth Lessans, MD, klessans@midlanticurology.com

    Kenneth Lessans, MD

    Recruiting

  • Advanced Urology Institute (Solaris)

    Largo, Florida, 33771

    Matthew Truesdale, MD, matthew.truesdale@auihealth.com

    Matthew Truesdale, MD

    Recruiting

  • Accellacare

    Lisle, Illinois, 60532

    Ranko Miocinovic, MD, 630-545-7760, Ranko.miocinovic@duly.com

    Ranko Miocinovic, MD

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Ahmet Aydin, MD, 501-526-5658, maydin@uams.edu

    Ahmet Aydin, MD

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansas, 72211

    Jon Henderson, MD, 501-219-8900, Jon@arkansasurology.com

    Jon Henderson, MD

    Recruiting

  • Urology Associates, Lone Tree

    Lone Tree, Colorado, 80124

    Daniel Mazur, MD, D.Mazur@uradenver.com

    Daniel Mazur, MD

    Recruiting

  • Genesis Research (Greater Los Angeles)

    Los Alamitos, California, 90720

    Sepehr Nowfar, MD, 424-667-2280, Sepehr.Nowfar@uniohp.com

    Sepehr Nowfar, MD

    Recruiting

  • Advanced Urology

    Los Angeles, California, 90045

    Withdrawn

  • Urologic Specialists of Northwest Indiana (Solaris)

    Merrillville, Indiana, 46410

    Manoj Rao, MD, 219-769-8641, mrao@urologic-specialists.com

    Manoj Rao, MD

    Recruiting

  • Urology Center of Southern California

    Murrieta, California, 92563

    Madhumitha Reddy, MD, mreddy@ucosc.com

    Madhumitha Reddy, MD

    Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 229572

    Neal Shore, MD, nshore@gsuro.com

    Neal Shore, MD

    Recruiting

  • Urology Associates, PC

    Nashville, Tennessee, 37209

    Gautam Jayram, MD, 615-250-9208, gtjayram@ua-pc.com

    Gautam Jayram, MD

    Recruiting

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

    Kyle Rose, MD, kyle.rose@ochsner.org

    Kyle Rose, MD

    Recruiting

  • Integrated Medical Professionals, PLLC (Solaris)

    New York, New York, 10016

    Jed Kaminetsky, MD, jkaminetsky@imppllc.com

    Jed Kaminetsky, MD

    Recruiting

  • Lowcountry Urology (Solaris)

    North Charleston, South Carolina, 29406

    Justin Ellett, MD, jellett@lcurology.com

    Justin Ellett, MD

    Recruiting

  • Adult and Adolescent Urology

    Omaha, Nebraska, 68114

    Andrew Trainer, MD, atrainer@adultpediatricuro.com

    Andrew Trainer, MD

    Recruiting

  • University of California, Irvine

    Orange, California, 92868

    Edward Uchio, MD, euchio@uci.edu

    Edward Uchio, MD

    Recruiting

  • Advanced Urology Institute

    Oxford, Florida, 34484

    Edward King, MD, 352-259-4400, edward.king@auihealth.com

    Edward King, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Trinity Bivalacqua, MD, trinity.bivalacqua@pennmedicine.upenn.edu

    Trinity Bivalacqua, MD

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Mark Tyson, MD, tyson.mark@mayo.edu

    Mark Tyson, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Jen-Jane Lui, MD, 503-346-0640, jenj@ohsu.edu

    Jen-Jabe Lui, ND

    Recruiting

  • Portland VA

    Portland, Oregon, 97239

    Nicholas Chakiryan, MD

    Nicholas Chakiryan, MD

    Recruiting

  • Associated Urologist of North Carolina (Solaris)

    Raleigh, North Carolina, 27612

    Mark Jalkut, MD, 919-782-1255, MJalkut@auncurology.com

    Mark Jalkut, MD

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Paras Shah, MD, Shah.Paras@mayo.edu

    Paras Shah, MD

    Recruiting

  • University of Rochester

    Rochester, New York, 14620

    William Tabayoyong, MD, william_tabayoyong@urmc.rochester.edu

    William Tabayoyong, MD

    Recruiting

  • Comprehensive Urology

    Royal Oak, Michigan, 48073

    Tarek Sangid, 248-336-1080 ext. 58754, TSangid@urologist.org

    Adam Gadzinski, MD

    Recruiting

  • UC Davis

    Sacramento, California, 95817

    Thenappan Chandrasekar, MD, 916-734-5959, tchandrasekar@health.ucdavis.edu

    Thenappan Chandrasekar, MD

    Recruiting

  • Urology San Antonio, PA dba USA Clinical Trials

    San Antonio, Texas, 78229

    Daniel Zainfeld, MD, 210-617-4116, Daniel.Zainfeld@urologysa.com

    Daniel Zainfeld, MD

    Recruiting

  • Om research

    San Diego, California, 91223

    Katayune Golshan, 858-429-7050 ext. 2668, kgolshan@omclinicaltrials.com

    Paul Dato, MD

    Recruiting

  • University of Southern California

    San Diego, California, 92123

    Siamak Daneshmand, MD, daneshma@med.usc.edu

    Siamek Daneshmand, MD

    Recruiting

  • Spokane Urology

    Spokane, Washington, 99202

    Shane Pearce, MD, 509-747-3147, pearce.shane@gmail.com

    Shane Pearce, MD

    Recruiting

  • Oregon Urology Institute

    Springfield, Oregon, 97447

    Katareanna Jeudy, 541-284-5508, kjeudy@oregonurology.com

    Bryan Mehlhaff, MD

    Recruiting

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141

    Gregory Auffenberg, MD, Gregory.Auffenberg@objective.health

    Gregory Auffenberg, MD

    Recruiting

  • SUNY Upstate

    Syracuse, New York, 13202

    Joseph Jacob, MD, jacobj@upstate.edu

    Joseph Jacob, MD

    Recruiting

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

    Syracuse, New York, 13210

    Christopher Pieczonka, MD, 315-478-4185, cpieczonka@ampofny.com

    Christopher Pieczonka, MD

    Recruiting

  • Advanced Urology Institute - Tallahassee (Solaris)

    Tallahassee, Florida, 32308

    Withdrawn

  • Montefiore Medical Center

    The Bronx, New York, 10461

    Alexander Sankin, MD, 347-842-1700, asankin@montefiore.org

    Alexander Sankin, MD

    Recruiting

  • Genesis Research (Greater Los Angeles)

    Torrance, California, 90503

    Timothy Lesser, MD, 424-667-2565, Timothy.Lesser@uniohp.com

    Timothy Lesser, MD

    Recruiting

  • Michigan Institute of Urology (Solaris)

    Troy, Michigan, 48084

    Jason Hafron, MD, 248-786-0467, HafronJ@michiganurology.com

    Jason Hafron, MD

    Recruiting

  • Arizona Urology Specialty

    Tucson, Arizona, 85704

    Withdrawn

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

    Michael Williams, MD, mwilliams@urologyofva.net

    Williams Michael, MD

    Recruiting

  • Wichita Urology Group

    Wichita, Kansas, 67226

    Philippe Nabbout, MD, pnabbout@wichitaurology.com

    Philippe Nabbout, MD

    Recruiting

  • Minnesota Urology

    Woodbury, Minnesota, 55123

    Aaron Milbank, MD, 651-999-6800, amilbank@mnurology.com

    Aaron Milbank, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Centre of Applied Urology Research Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

    Ricardo Rendon, MD, 902.425.3940, ricardo.rendon@dal.ca

    Ricardo Rendon, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Cretostimogene Grenadenorepvec
Keywords
Bladder Cancer
Medical subject headings
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

    Respective Cohort

Study groups in NCT06567743
Study groupRoleWhat they receive
Experimental: Cohort A, Arm 1ExperimentalCretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method
Receives: Drug: Cretostimogene Grenadenorepvec
Experimental: Cohort A, Arm 2ExperimentalCretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Receives: Drug: Cretostimogene Grenadenorepvec
Experimental: Cohort A, Arm 3ExperimentalCretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Receives: Drug: Cretostimogene Grenadenorepvec
Experimental: Cohort B, Arm 1ExperimentalCretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Receives: Drug: Cretostimogene Grenadenorepvec
Experimental: Cohort B, Arm 2ExperimentalCretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Receives: Drug: Cretostimogene Grenadenorepvec
Experimental: Cohort CX, Arm 1ExperimentalAt all treatment visits cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method followed by gemcitabine instilled intravesically
Receives: Drug: Cretostimogene Grenadenorepvec
Experimental: Cohort CX, Arm 2ExperimentalCretostimogene (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
Receives: Drug: Cretostimogene Grenadenorepvec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort A (Arm 1 and 2): Complete response rate

    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

    Measured: At 11 and 24 weeks

  2. Cohort A (Arm 3): High- Grade Event-Free Survival

    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.

    Measured: 48 months

  3. Cohort B (Arm 1): Complete response rate

    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.

    Measured: At 11 and 24 weeks

  4. Cohort B (Arm 2): High-Grade Event-Free Survival

    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.

    Measured: 48 months

  5. Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival

    Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.

    Measured: 48 months

  6. Cohort CX (Arms 1 and 2): Safety

    Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.

    Measured: 48 months

Secondary outcomes (5)

  1. Cohort A (Arms 1 and 2): Evaluate cretostimogene instillation methods

    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.

    Measured: At 11 and 24 weeks

  2. Cohort A (Arm 3): High-Grade Event-Free Survival 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

    Measured: At 12 months

  3. Cohort A (Arms 1 and 2) and Cohort B (Arm 1) Duration of response

    Assess duration of response in participants with CIS with or without concomitant HG Ta/T1 disease at baseline

    Measured: 48 months

  4. Cohort B (Arm 2) High-Grade Event-Free Survival 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

    Measured: At 12 months

  5. Cohort CX (Arm 1 and 2) Complete response rate

    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.

    Measured: At 11 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2024
  2. Study start16 Sep 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
325 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06567743
Sponsor's protocol ID
CORE-008
Status last verified
Sep 2026
First submitted
14 Aug 2024
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cretostimogene Grenadenorepvec in people with High-Risk Non-Muscle-Invasive Bladder Cancer, run by CG Oncology, Inc. at 80 sites in 2 countries.

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 0 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 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 80 sites in United States, Canada. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rebecca Tregunna, MD (949 409-3700, Rebecca.Tregunna@cgoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort A (Arm 1 and 2): Complete response rate (time frame: At 11 and 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06567743.

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 3 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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