Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Purpose
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.
Condition
- High-Risk Non-Muscle-Invasive Bladder Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 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.
Exclusion Criteria
(Both Cohorts): - Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer. - High-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. - Significant immunodeficiency. - Pregnant or breastfeeding. - Cohort CX Only: serial intravesical gemcitabine within 24 months
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental: Cohort A, Arm 1 |
Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method |
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|
Experimental Experimental: Cohort A, Arm 2 |
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method. |
|
|
Experimental Experimental: Cohort A, Arm 3 |
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method. |
|
|
Experimental Experimental: Cohort B, Arm 1 |
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method. |
|
|
Experimental Experimental: Cohort B, Arm 2 |
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method. |
|
|
Experimental Experimental: Cohort CX, Arm 1 |
At all treatment visits cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method followed by gemcitabine instilled intravesically |
|
|
Experimental Experimental: Cohort CX, Arm 2 |
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 |
|
Recruiting Locations
Phoenix 5308655, Arizona 5551752 85054
Tucson 5318313, Arizona 5551752 85704
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72211
Bakersfield 5325738, California 5332921 93301
Michael G Oefelein, MD
661-310-1063
Los Alamitos 5368304, California 5332921 90720
Los Angeles 5368361, California 5332921 90045
Murrieta 5375911, California 5332921 92563
Orange 5379513, California 5332921 92868
San Diego 5391811, California 5332921 92123
Torrance 5403022, California 5332921 90503
Lakewood 5427946, Colorado 5417618 80228
Lone Tree 5429208, Colorado 5417618 80124
Jacksonville 4160021, Florida 4155751 32224
Largo 4161580, Florida 4155751 33771
Oxford 4167381, Florida 4155751 34484
Tallahassee 4174715, Florida 4155751 32308
Atlanta 4180439, Georgia 4197000 30322
Chicago Ridge 4887492, Illinois 4896861 60415
Glenview 4893886, Illinois 4896861 60026
Carmel 4255466, Indiana 4921868 46032
Greenwood 4258313, Indiana 4921868 46143
Jeffersonville 4259671, Indiana 4921868 47130
Merrillville 4923482, Indiana 4921868 46410
Clive 4852065, Iowa 4862182 50325
Wichita 4281730, Kansas 4273857 67226
Lafayette 4330145, Louisiana 4331987 70508
New Orleans 4335045, Louisiana 4331987 70121
Hanover 4357340, Maryland 4361885 21076
Troy 5012639, Michigan 5001836 48084
Rochester 5043473, Minnesota 5037779 55905
Woodbury 5053358, Minnesota 5037779 55123
St Louis 4407066, Missouri 4398678 63141
Omaha 5074472, Nebraska 5073708 68114
New York 5128581, New York 5128638 10016
Rochester 5134086, New York 5128638 14620
Syracuse 5140405, New York 5128638 13210
The Bronx 5110266, New York 5128638 10461
Cincinnati 4508722, Ohio 5165418 45212
Cincinnati 4508722, Ohio 5165418 45267
Gahanna 5155393, Ohio 5165418 43230
Bala-Cynwyd 5178892, Pennsylvania 6254927 19004
Lancaster 5197079, Pennsylvania 6254927 17604
Philadelphia 4560349, Pennsylvania 6254927 19104
Charleston 4574324, South Carolina 4597040 25304
Myrtle Beach 4588718, South Carolina 4597040 229572
North Charleston 4589387, South Carolina 4597040 29406
Germantown 4624601, Tennessee 4662168 38138
Nashville 4644585, Tennessee 4662168 37209
Amarillo 5516233, Texas 4736286 79106
Arlington 4671240, Texas 4736286 76017
Austin 4671654, Texas 4736286 78745
Dallas 4684888, Texas 4736286 75231
Houston 4699066, Texas 4736286 77030
San Antonio 4726206, Texas 4736286 78229
Virginia Beach 4791259, Virginia 6254928 23462
Spokane 5811696, Washington 5815135 99202
More Details
- NCT ID
- NCT06567743
- Status
- Recruiting
- Sponsor
- CG Oncology, Inc.
Detailed Description
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.