An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
Purpose
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
Conditions
- Non-Muscle Invasive Bladder Cancer
- Urothelial Carcinoma
- Urologic Cancer
- Bladder Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following: - Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease) - Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 15 months of the initial qualifying dose of BCG. 2. Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment 3. Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment. 4. Acceptable baseline organ function
Exclusion Criteria
- Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer. 2. Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed. 3. Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1 4. Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
Bakersfield 5325738, California 5332921 93301
Murrieta 5375911, California 5332921 92563
Washington D.C. 4140963, District of Columbia 4138106 20010
Daytona Beach 4152872, Florida 4155751 32114
Largo 4161580, Florida 4155751 33771
Chicago Ridge 4887492, Illinois 4896861 60415
Glenview 4893886, Illinois 4896861 60026
Merrillville 4923482, Indiana 4921868 46410
Clive 4852065, Iowa 4862182 50325
Troy 5012639, Michigan 5001836 40484
Southaven 4446675, Mississippi 4436296 38671
New York 5128581, New York 5128638 10016
Bala-Cynwyd 5178892, Pennsylvania 6254927 19004
North Charleston 4589387, South Carolina 4597040 29406
Arlington 4671240, Texas 4736286 76017
Dallas 4684888, Texas 4736286 75231
San Antonio 4726206, Texas 4736286 78229
Wichita Falls 4741752, Texas 4736286 76301
Spokane 5811696, Washington 5815135 99202
More Details
- NCT ID
- NCT06443944
- Status
- Available
- Sponsor
- CG Oncology, Inc.
Detailed Description
All participants will be assigned the same treatment schedule. Participants will receive an induction course of 6 weekly treatments, and, if there is no disease recurrence at Week 13, participants will receive a cycle of 3 weekly treatments up to Week 15. If there is persistent HG Ta and/or CIS at Week 13, participants may receive a second induction cycle. If the participant has persistent but improved HG Ta and/or CIS at Week 25 or a later timepoint, the participant may receive a cycle of 3 weekly treatments of cretostimogene at the discretion of the Investigator provided that T1 or higher stage of urothelial carcinoma is not present. If there is no disease present at Week 25 or a later timepoint, participants will receive a cycle of 3 weekly treatments every 12 weeks through Month 12. After Month 12, participants will receive a cycle of 3 weekly treatments every 6 months through the last treatment cycle at Month 24, or until discontinuation from the study treatment. Disease status will be assessed based on local standard of care (which may include urine cytology, cystoscopy, and directed TURBT/biopsy) every 12 weeks. CTU/MRU can be done per standard of care evaluation at investigator's discretion.