AVAILABLENot Applicable

An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

United States

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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:
✓. 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.
✓. Acceptable baseline organ function

Exclusion criteria

✕. 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 details

NCT IDNCT06443944

SponsorCG Oncology, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

Contact for this trial

Rob Svatek, MD

(949) 419-6203 recruitment@cgoncology.com

View on ClinicalTrials.gov More Non-Muscle Invasive Bladder Cancer trials