Brief Title: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Sponsor: CG Oncology, Inc.
ClinicalTrials ID:NCT06567743
This Phase 2 study evaluates the safety and efficacy of cretostimogene grenadenorepvec with DDM in BCG-naïve, high-risk NMIBC patients. Up to 50 participants will be randomized to two arms with different instillation procedures. Eligibility includes confirmed CIS-containing NMIBC and acceptable organ function. Treatment involves induction, maintenance, and disease monitoring over several years.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Description
In Cohort A, up to 50 participants will be enrolled with pathologically confirmed, CIS-containing, high-risk NMIBC (i.e., CIS with or without concomitant Ta/T1) who are naïve to BCG treatment. Participants will be randomized 1:1 to receive DDM and cretostimogene via the current (Arm 1) or an alternative instillation procedure (Arm 2).
Cretostimogene and DDM 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 and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for a further 2 years or until disease recurrence.
Eligibility Criteria
Inclusion Criteria
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Pathologically confirmed BCG-naïve, CIS-containing (i.e., CIS with or without concomitant HG Ta/T1) high-risk NMIBC within 90 days of randomization.
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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.
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All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to randomization.
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arkansas Urology | 72211 | Little Rock | Arkansas |
| Michael G Oefelein, MD Clinical Trials | 93301 | Bakersfield | California |
| Genesis Research (Greater Los Angeles) | 90720 | Los Alamitos | California |
| Genesis Research (Greater Los Angeles) | 90503 | Torrance | California |
| Urology Associates, Lone Tree | 80124 | Lone Tree | Colorado |
| Advanced Urology Institute (Solaris) | 33771 | Largo | Florida |
| Advanced Urology Institute | 34484 | Oxford | Florida |
| Associated Urological Specialists | 60415 | Chicago Ridge | Illinois |
| Urology of Indiana, LLC (US Urology Partners) | 46143 | Greenwood | Indiana |
| First Urology, PSC | 47130 | Jeffersonville | Indiana |
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