CG0070 in NMIBC Unresponsive to BCG - BOND-003 (Bladder Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an investigational drug called CG0070 (the study drug) is safe and effective for patients who have NMIBC that does not respond to BCG treatment.
What is the Condition Being Studied?
Non-Muscular Invasive Bladder Cancer (NMIBC)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with NMIBC
- Have received BCG therapy but did not respond
- Are not pregnant
- Do not have heart, kidney, or gastrointestinal disease
For more information about who can join this study, please contact the study team at urologyresearch@duke.edu.
Age Group
Adults
What is Involved?
If you choose to join this study, you will receive the study drug directly into the bladder through a catheter every week for 6 weeks. You might receive more doses of the study drug after 6 weeks, which will depend on how you respond to the study regimen.
All participants will:
- Have blood and urine tests
- Have tumor samples taken
- Have physical exams
- Have images taken (CT scans)
- Have follow-up visits every 24-28 weeks after stopping the study drug
Participation in this study lasts up to 4 years.
Study Details
Full Title
A Phase 3 Study of CG0070 in Patients with Non-Muscular Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
Principal Investigator
Urologic Oncologist
Protocol Number
IRB:
PRO00107529
NCT:
NCT04452591
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment