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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)

Phase
Phase 2
Sponsor
CG Oncology, Inc.
Enrollment
325
Timeline
Sep 2024 → Dec 2027
About This Study

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 Criteria

Inclusion Criteria

  • 1Pathologically 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.
  • 2All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
  • 3Acceptable baseline organ function.
  • 4Pathologically 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.
  • 5All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
  • 6Acceptable baseline organ function.
  • 7Pathologically 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.
  • 8All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
  • 9Acceptable baseline organ function.

Exclusion Criteria

  • 1Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.
  • 2High-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.
  • 3Significant immunodeficiency.
  • 4Pregnant or breastfeeding.
  • 5Cohort CX Only: serial intravesical gemcitabine within 24 months

Locations

58 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

Shreyas Joshi, MD

Mayo Clinic Arizona

Phoenix, Arizona 85054

Recruiting

Mark Tyson, MD

Arizona Urology Specialty

Tucson, Arizona 85704

Recruiting

Kenneth Belkoff, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →