NCT02143804

Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer

Phase II Safety and Efficacy Study of CG0070 Oncolytic Vector Regimen in Patients With High Grade Non-Muscle Invasive Bladder Carcinoma Disease (NMIBC) Who Have Failed BCG and Refused Cystectomy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CG Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and Cis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol (NCT 01438112), or in high grade Ta and T1 patients who failed BCG therapy.

Detailed description

The plan is to study the safety and efficacy of CG0070 in high-grade NMIBC patients who failed BCG therapy. Most patients with NMIBCis (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. CG0070, if successful in this trial, will serve to provide a therapeutic alternative for this patient population in need. For the present study, Cis or Cis with Ta and/or T1 patients can only be enrolled if they have failed the BOND study and are medically unfit for surgery. Furthermore, patients with high grade Ta or T1 disease who have failed both BCG and chemotherapy treatments are also prone to disease progression. Since these patients are not eligible to be enrolled in the BOND trial, the present study will serve as an alternative to access CG0070 experimental treatment.

Conditions

• Bladder Cancer
• High Grade
• Non Muscle Invasive

Interventions

Type	Name	Description
BIOLOGICAL	oncolytic adenovirus expressing GMCSF	Treatment once weekly by intravesical route. Use of DDM to first remove the GAG layer of the bladder and to improve virus transduction. Installation of 100 ml. of CG0070 at 10e12 viral particles for 45 minutes inside bladder.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-05-21
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States