Status:
RECRUITING
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Lead Sponsor:
CG Oncology, Inc.
Conditions:
High-Risk Non-Muscle-Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 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 T...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT06567743
Start Date
September 16 2024
End Date
December 30 2027
Last Update
October 8 2025
Active Locations (58)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
Arizona Urology Specialty
Tucson, Arizona, United States, 85704
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Arkansas Urology
Little Rock, Arkansas, United States, 72211