RecruitingPhase 2NCT06567743
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
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)
Sponsor
CG Oncology, Inc.
Enrollment
325 participants
Start Date
Sep 16, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- 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.
- 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.
- 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.
Exclusion Criteria5
- 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
Interventions
DRUGCretostimogene Grenadenorepvec
Respective Cohort
Locations(65)
View Full Details on ClinicalTrials.gov
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NCT06567743