This is an open-label, expanded access trial designed to provide access to cretostimogenein patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
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.
Drug: Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
Other Name: CG0070
Other: n-dodecyl-B-D-maltoside
Transduction-enhancing agent
Other Name: DDM
Inclusion Criteria:
1. 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:
1. 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.
Michael G. Oefelein Clinical Trials
Bakersfield, California, United States
McR, Llc.
Murrieta, California, United States
Advanced Urology Institute
Largo, Florida, United States
Emory University
Atlanta, Georgia, United States
Uropartners c/o Associated Urological Specialists
Chicago Ridge, Illinois, United States
Urology Center of Iowa Research
Clive, Iowa, United States
Integrated Medical Professionals, PLLC
New York, New York, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Amarillo Urology Research
Amarillo, Texas, United States
Urology Partners of North Texas Research Institute
Arlington, Texas, United States
Urology San Antonio, PA dba USA Clinical Trials
San Antonio, Texas, United States
Spokane Urology
Spokane, Washington, United States
Andy Darilek, MD
949-419-6149
recruitment@cgoncology.com
Vijay Kasturi, MD
949-419-6149
recruitment@cgoncology.com
Not Provided