Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk 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.
Inclusion Criteria
- Cohort A Key Inclusion Criteria: - Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. - All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. - Acceptable baseline organ function. Cohort B Key Inclusion Criteria: - Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. - All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. - Acceptable baseline organ function. Cohort CX Inclusion Criteria - Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. - All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. - Acceptable baseline organ function. Key Exclusion Criteria (Both Cohorts): - 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06567743.
Locations matching your search criteria
United States
Arizona
Scottsdale
California
Irvine
Los Angeles
Orange
Sacramento
Florida
Gainesville
Jacksonville
Georgia
Atlanta
Massachusetts
Boston
Minnesota
Rochester
New Jersey
Hackensack
New York
Bronx
Rochester
North Carolina
Chapel Hill
Charlotte
Ohio
Cleveland
Columbus
Oregon
Portland
Texas
Dallas
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.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationCG Oncology, Inc.
Principal InvestigatorPat Keegan
- Primary IDCORE-008
- Secondary IDsNCI-2024-08550
- ClinicalTrials.gov IDNCT06567743