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

• Conditions: Urothelial Carcinoma; Bladder Cancer; Non-Muscle Invasive Bladder Cancer; Urologic Cancer

• Registration Number: NCT06443944
• Lead Sponsor: CG Oncology, Inc.

Brief Summary

This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC unresponsive to BCG.

Detailed Description

All participants will be assigned the same treatment schedule. Participants will receive an induction course 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 course.

If there is no disease present thereafter, participants will receive 3 weekly treatment cycles every 12 weeks through Month 12.

After Month 12, participants will receive 3 weekly treatment cycles every 6 months through the last treatment cycle at Month 24, or until discontinuation from the study treatment.

Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 12 weeks and CTU/MRU every 24 weeks, for up to 2 years.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Related News

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-05
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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:

  1. Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease) within 12 months of last dose of adequate BCG treatment for HGUC.
  2. Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG.
  3. Pathological confirmation of BCG unresponsive CIS within 16 weeks of study enrollment.
  4. CIS specimen must be predominantly urothelial (transitional cell) and have less than 50% variant histology.
  5. No maximum limit to the amount of BCG administered; however, there should be no more than 12 months between cycles of BCG.

• Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment NOTE: T1 disease resection site must have biopsy evaluation of the prior resection site 2-12 weeks prior to initial study treatment.

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

• Acceptable baseline organ function

Read More

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 anti-cancer therapy, including investigational agents, within 4 weeks of Day 1
• Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 6 weeks after the last study treatment.

Read More

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified