NCT06567743 · CG Oncology, Inc.
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
What this study is about
This is a Phase 2, Multi-treatment group$1, Multi-group of participants, where both patients and doctors know the treatment given Study to Evaluate the Safety and effectiveness of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.
View original scientific description
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.
Interventions
DRUG
Cretostimogene Grenadenorepvec
Respective Cohort
Primary outcome measures
Cohort A (Arm 1 and 2): Complete response rate
Time frame: At 11 and 24 weeks
Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-naïve CIS with or without concomitant high-grade Ta or T1 disease at baseline
Cohort A (Arm 3): High- Grade Event-Free Survival
Time frame: 48 months
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-naïve HG Ta/T1 disease without concomitant CIS at baseline.
Cohort B (Arm 1): Complete response rate
Time frame: At 11 and 24 weeks
Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-exposed CIS with or without concomitant high-grade Ta or T1 disease at baseline.
Cohort B (Arm 2): High-Grade Event-Free Survival
Time frame: 48 months
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed high-grade Ta/T1 papillary disease without CIS at baseline.
Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival
Time frame: 48 months
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.
Cohort CX (Arms 1 and 2): Safety
Time frame: 48 months
Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 papil
Where
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Bakersfield, California
- Los Alamitos, California
- Los Angeles, California
- Murrieta, California
- Orange, California
- San Diego, California
- Torrance, California
- Lakewood, Colorado
- Lone Tree, Colorado
And 48 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations