Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin (BOND-003)
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|ClinicalTrials.gov Identifier: NCT04452591|
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : May 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non Muscular Invasive Bladder Cancer||Biological: CG0070 Other: n-dodecyl-B-D-maltoside||Phase 3|
An open-label trial designed to evaluate CG0070 + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that will enroll up to 110 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease
BCG failure is defined as a persistent or recurrent disease within 12 months of completion of adequate BCG therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)|
|Actual Study Start Date :||October 27, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2024|
Experimental: Single Arm
Patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.
CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g. complete response) then the patient will receive 3 weekly treatments.
Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 49then every 24 weeks thereafter.
Engineered Oncolytic Adenovirus
Other Name: DDM
- Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease) [ Time Frame: 24 months ]Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
- Median Duration of response (DOR) [ Time Frame: 24 months ]Median duration of response in patients with a CR or PR in subjects
- Median progression free survival [ Time Frame: 24 months ]Median duration of progression free survival of subjects
- Time to tumor progression (TTP) [ Time Frame: 24 months ]Median time until patient disease progression (PD) in subjects
- Incidence of adverse events when CG0070 administered alone. [ Time Frame: 24 months ]Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0.
- Comparison of complete response in patients with persistent disease versus relapsed disease at baseline. [ Time Frame: 24 months ]Percentage in CR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452591
|Contact: Stephanie Harrisfirstname.lastname@example.org|
|Principal Investigator:||James Burke, MD||CG Oncology, Inc.|