A Phase 2 interventional study of Cretostimogene Grenadenorepvec in High-Risk Non-Muscle-Invasive Bladder Cancer, sponsored by CG Oncology, Inc.. Recruiting at 80 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by CG Oncology, Inc. · Phase 2, Interventional, and Treatment
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.
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 T1 disease OR HG Ta/T1 disease without CIS) which is naïve to Bacillus Calmette-Guerin (BCG) treatment. Participants with CIS with or without concomitant Ta/T1 NMIBC at baseline will be randomized 1:1 to receive cretostimogene via the current (Arm 1) or an alternative instillation procedure (Arm 2). Participants with papillary-only high-risk NMIBC (i.e., HG Ta/T1 without CIS) at baseline (Arm 3) will receive cretostimogene via the alternative instillation procedure.
In Cohort B, up to 150 participants will be enrolled with pathologically confirmed, high-risk high-grade NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which has previously been exposed to BCG treatment. Participants with CIS-containing pathology at baseline will be recruited into Arm 1 and participants with papillary-only pathology at baseline will be recruited into Arm 2. Both Cohort B Arms 1 and 2 will receive cretostimogene via the alternative instillation procedure.
In Cohort CX, up to 50 participants will be enrolled with pathologically confirmed, high-risk high-grade NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which has previously been exposed to or is unresponsive to BCG treatment. Participants will be randomized 1:1 to receive cretostimogene and gemcitabine either concurrently or sequentially.
In all cohorts, study treatment will be administered as a weekly induction course for the first 6 weeks with a reinduction course administered to patients who have CIS and/or high-grade Ta disease at the 3-month evaluation. Following induction, if no high-grade disease is detected, maintenance treatment will begin. This consists of a cycle of three weekly treatments every three months during the first year, and every six months during the second year, with an optional extension to the third year following the same six-month schedule.
Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), upper tract assessment and directed resection/biopsy (if indicated) every 3 months for the first 2 years and then every 6 months for a further 2 years or until disease recurrence.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 325 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →CG Oncology, Inc. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort A Key Inclusion Criteria:
Cohort B Key Inclusion Criteria:
Cohort CX Inclusion Criteria
Key Exclusion Criteria (Both Cohorts):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method
Drug: Cretostimogene Grenadenorepvec
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Drug: Cretostimogene Grenadenorepvec
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Drug: Cretostimogene Grenadenorepvec
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Drug: Cretostimogene Grenadenorepvec
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Drug: Cretostimogene Grenadenorepvec
At all treatment visits cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method followed by gemcitabine instilled intravesically
Drug: Cretostimogene Grenadenorepvec
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method for two consecutive weeks, followed by gemcitabine administered intravesically in the third week on a cyclic 2:1 visit schedule basis
Drug: Cretostimogene Grenadenorepvec
Respective Cohort
Also known as: CG0070
Cohort A (Arm 1 and 2): Complete response rate
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
Time frame: At 11 and 24 weeks
Cohort A (Arm 3): High- Grade Event-Free Survival
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.
Time frame: 48 months
Cohort B (Arm 1): Complete response rate
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.
Time frame: At 11 and 24 weeks
Cohort B (Arm 2): High-Grade Event-Free Survival
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.
Time frame: 48 months
Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.
Time frame: 48 months
Cohort CX (Arms 1 and 2): Safety
Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.
Time frame: 48 months
Cohort A (Arms 1 and 2): Evaluate cretostimogene instillation methods
Evaluate cretostimogene genome and GM-CSF levels, treatment efficacy, and safety by 2 different methods of cretostimogene instillation in participants with pathologically confirmed CIS-containing high-risk NMIBC who are naïve to BCG treatment.
Time frame: At 11 and 24 weeks
Cohort A (Arm 3): High-Grade Event-Free Survival at 12 months
Determine the proportion of participants with BCG-naive papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months
Time frame: At 12 months
Cohort A (Arms 1 and 2) and Cohort B (Arm 1) Duration of response
Assess duration of response in participants with CIS with or without concomitant HG Ta/T1 disease at baseline
Time frame: 48 months
Cohort B (Arm 2) High-Grade Event-Free Survival at 12 months
Determine the proportion of participants with BCG-exposed papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months
Time frame: At 12 months
Cohort CX (Arm 1 and 2) Complete response rate
Determine the complete response rate at any time following treatment with cretostimogene and gemcitabine in participants with BCG-exposed or BCG-unresponsive CIS with or without concomitant high-grade Ta or T1 disease at baseline.
Time frame: At 11 and 24 weeks
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Mar 2027, 30 months after the start.
Of 39 industry-sponsored phase 2 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 52. This study's planned 30 months is below that.
Counting every sponsor, half of 194 studies reached it within 52 months; a quarter within 36 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cretostimogene grenadenorepvec
CG Oncology, Inc.