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)

INTRODUCTION

  • Org Study ID: CORE-008
  • Secondary ID: N/A
  • NCT ID: NCT06567743
  • Sponsor: CG Oncology, Inc.

BRIEF 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.

DETAILED DESCRIPTION

In Cohort A, up to 50 participants will be enrolled with pathologically confirmed, CIS-containing, high-risk NMIBC (i.e., CIS with or without concomitant Ta/T1) who are naïve to BCG treatment. Participants will be randomized 1:1 to receive DDM and cretostimogene via the current (Arm 1) or an alternative instillation procedure (Arm 2).

Cretostimogene and DDM 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 and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for a further 2 years or until disease recurrence.

  • Overall Status
    Recruiting
  • Start Date
    September 16, 2024
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Cohort A: Complete response rate

Primary Outcome 1 - Timeframe: At 11 and 24 weeks

CONDITION

  • High-Risk Non-Muscle-Invasive Bladder Cancer

ELIGIBILITY

Cohort A Key Inclusion Criteria:
* Pathologically confirmed BCG-naïve, CIS-containing (i.e., CIS with or without concomitant HG Ta/T1) high-risk NMIBC within 90 days of randomization.

- * Participants with BCG-naïve NMIBC should have either:
* No prior treatment with BCG OR

- * No treatment with BCG within the past 24 months prior to current pathological diagnosis OR

- * A maximum of 1 or 2 doses of BCG within the past 24 months prior to current pathological diagnosis.

- * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to randomization.

- * Acceptable baseline organ function.
Key Exclusion Criteria:
* Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.

- * High-grade disease in the upper urinary tract or prostatic urethra within 24 months of randomization or any history of muscle-invasive, locally advanced or metastatic disease in the upper urinary tract.

- * Significant immunodeficiency.

- * Pregnant or breastfeeding.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pat Keegan

Role: Study Director

Affiliation: CG Oncology

Overall Contact

Name: Rebecca Tregunna, MD, Andy Darilek

Phone: +1.949.419.6105, +1.406.628.5708

Email: [email protected], [email protected]

LOCATION

Facility Status Contact
Facility: Arkansas Urology
Little Rock, Arkansas 72211
United States
Status: Recruiting Contact: Contact
Jon Henderson, MD
501-219-8900
[email protected]

Principal Investigator
Jon Henderson, MD

Facility: Michael G Oefelein, MD Clinical Trials
Bakersfield, California 93301
United States
Status: Recruiting Contact: Contact
Michael G Oefelein, MD
661-310-1063

Principal Investigator
Michael G Oefelein, MD

Facility: Genesis Research (Greater Los Angeles)
Los Alamitos, California 90720
United States
Status: Recruiting Contact: Contact
Sepehr Nowfar, MD
424-667-2280
[email protected]

Principal Investigator
Sepehr Nowfar, MD

Facility: Genesis Research (Greater Los Angeles)
Torrance, California 90503
United States
Status: Recruiting Contact: Contact
Timothy Lesser, MD
424-667-2565
[email protected]

Principal Investigator
Timothy Lesser, MD

Facility: Urology Associates, Lone Tree
Lone Tree, Colorado 80124
United States
Status: Recruiting Contact: Contact
Daniel Mazur, MD
[email protected]

Principal Investigator
Daniel Mazur, MD

Facility: Advanced Urology Institute (Solaris)
Largo, Florida 33771
United States
Status: Recruiting Contact: Contact
Matthew Truesdale, MD
[email protected]

Principal Investigator
Matthew Truesdale, MD

Facility: Advanced Urology Institute
Oxford, Florida 34484
United States
Status: Recruiting Contact: Contact
Edward King, MD
352-259-4400
[email protected]

Principal Investigator
Edward King, MD

Facility: Associated Urological Specialists
Chicago Ridge, Illinois 60415
United States
Status: Recruiting Contact: Contact
Aaron Berger, MD
[email protected]

Principal Investigator
Aaron Berger, MD

Facility: Urology of Indiana, LLC (US Urology Partners)
Greenwood, Indiana 46143
United States
Status: Recruiting Contact: Contact
Eugene Cone, MD
317-564-5573
[email protected]

Principal Investigator
Eugene Cone, MD

Facility: First Urology, PSC
Jeffersonville, Indiana 47130
United States
Status: Recruiting Contact: Contact
Ryan Malone, MD
812-206-8164
[email protected]

Principal Investigator
Ryan Malone, MD

Facility: Urologic Specialists of Northwest Indiana (Solaris)
Merrillville, Indiana 46410
United States
Status: Recruiting Contact: Contact
Manoj Rao, MD
314-443-1168
[email protected]

Principal Investigator
Manoj Rao, MD

Facility: Urology Center of Iowa Research
Clive, Iowa 50325
United States
Status: Recruiting Contact: Contact
Brian Gallagher, MD
515-992-7718
[email protected]

Principal Investigator
Brian Gallagher, MD

Facility: Southern Urology (Urology America)
Lafayette, Louisiana 70508
United States
Status: Recruiting Contact: Contact
Jason Bourque, MD
337-422-3738
[email protected]

Principal Investigator
Jason Bourque, MD

Facility: Michigan Institute of Urology (Solaris)
Troy, Michigan 48084
United States
Status: Recruiting Contact: Contact
Jason Hafron, MD
248-786-0467
[email protected]

Principal Investigator
Jason Hafron, MD

Facility: Integrated Medical Professionals, PLLC (Solaris)
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Jed Kaminetsky, MD
[email protected]

Principal Investigator
Jed Kaminetsky, MD

Facility: Associated Medical Professionals of NY, PLLC (US Urology Partners)
Syracuse, New York 13210
United States
Status: Recruiting Contact: Contact
Christopher Pieczonka, MD
315-478-4185
[email protected]

Principal Investigator
Christopher Pieczonka, MD

Facility: The Urology Group (Solaris)
Cincinnati, Ohio 45212
United States
Status: Recruiting Contact: Contact
Marc Pliskin, MD
[email protected]

Principal Investigator
Marc Pliskin, MD

Facility: Central Ohio Urology Group (US Urology Partners)
Gahanna, Ohio 43230
United States
Status: Recruiting Contact: Contact
Benjamin Martin, MD
614-396-2684
[email protected]

Principal Investigator
Benjamin Martin, MD

Facility: Midlantic Urology (Solaris)
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Laurence Belkoff, MD
[email protected]

Principal Investigator
Laurence Belkoff, MD

Facility: Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 229572
United States
Status: Recruiting Contact: Contact
Neal Shore, MD
[email protected]

Principal Investigator
Neal Shore, MD

Facility: Lowcountry Urology (Solaris)
North Charleston, South Carolina 29406
United States
Status: Recruiting Contact: Contact
Justin Ellett, MD
[email protected]

Principal Investigator
Justin Ellett, MD

Facility: The Conrad Pearson Clinic (Urology America)
Germantown, Tennessee 38138
United States
Status: Recruiting Contact: Contact
Michael Granieri, MD
901-236-0957
[email protected]

Principal Investigator
Michael Granieri, MD

Facility: Urology Associates, PC
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Gautam Jayram, MD
615-250-9208
[email protected]

Principal Investigator
Gautam Jayram, MD

Facility: UPNT Research Institute, LLC
Arlington, Texas 76017
United States
Status: Recruiting Contact: Contact
Michael Collini, MD
682-205-8396
[email protected]

Principal Investigator
Michael Collini, MD

Facility: Urology Austin, PLLC (Urology America)
Austin, Texas 78745
United States
Status: Recruiting Contact: Contact
Brian Mazzarella, MD
512-410-3773
[email protected]

Principal Investigator
Brian Mazzarella

Facility: Urology Clinics of North Texas, PLLC
Dallas, Texas 75231
United States
Status: Recruiting Contact: Contact
Jacob Taylor, MD
214-556-8337
[email protected]

Principal Investigator
Jacob Taylor, MD

Facility: Urology San Antonio, PA dba USA Clinical Trials
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Daniel Zainnfeld, MD
210-617-4116
[email protected]

Principal Investigator
Daniel Zainfeld, MD

Facility: Spokane Urology
Spokane, Washington 99202
United States
Status: Recruiting Contact: Contact
Shane Pearce, MD
509-747-3147
[email protected]

Principal Investigator
Shane Pearce, MD