NCT02365818

Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure

An Open Label, Single Arm, Phase II, Multicenter Study of the Safety and Efficacy of CG0070 Oncolytic Vector Regimen in Patients With Non-Muscle Invasive Bladder Carcinoma Who Have Failed BCG (Bacillus Calmette-Guerin) Therapy and Refused Cystectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: CG Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To study the safety and efficacy of CG0070, an oncolytic virus expression GM-CSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.

Detailed description

The plan is to study the safety and efficacy of CG0070 in high-grade NMIBC (Non-muscle Invasive Bladder Cancer) 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 (Bacillus Calmette-Guerin) 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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CG0070

Timeline

• Start date: 2015-06-02
• Primary completion: 2018-08-01
• Completion: 2019-02-01
• First posted: 2015-02-19
• Last updated: 2021-04-14

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study