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)

Condition: High-Risk Non-Muscle-Invasive Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06567743

Sponsor: CG Oncology, Inc.

Phase: Phase 2

Eligibility:

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.