Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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.

Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment

Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.

Disqualifiers

Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.

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.

Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1

Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.

Trial design

Treatments tested in this trial

  • Cretostimogene Grenadenorepvec
  • n-dodecyl-B-D-maltoside

Treatment groups

No treatment groups listed

Locations

26
Arizona
Banner MD Anderson Cancer Center85234, Gilbert United States
California
Michael G. Oefelein Clinical Trials93301, Bakersfield United States
University of Southern California / Norris Comprehensive Cancer Center90033, Los Angeles United States
McR, Llc.92563, Murrieta United States

Sponsors and collaborators

CG Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov