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.
Who Can Participate?
Eligibility
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
Age Range
18-90
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Ankeet
Shah
Protocol Number
PRO00107529
NCT ID
NCT04452591
Phase
III
Enrollment Status
Open to Enrollment