Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC
A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin
Doctors at several coordinating centers in 37 states seek patients with Non-muscle Invasive Bladder Cancer (NIMBC) unresponsive to Bacillus Calmette-Guerin (BCG) therapy. The investigational drug, BC-819, is a genetically engineered loop of DNA, or plasmid, that instructs only the genes of malignant tumor cells to produce a toxin that can kill the cancer cells. By design, the toxin cannot travel to other cells.
The goal of this large clinical trial is to see bladder cancer resolve completely and measure its rate of non-recurrence. The injections into the bladder are brief but will recur weekly for 10 treatments, then every 3 weeks for up to 84 weeks.
- Be 18 years or older
- Have been adequately treated but unresponsive with BCG according to specific FDA guidelines
- Patient must have no known evidence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra within 6 months of enrollment
- Patient must have adequate liver and renal function
- Female patients of childbearing potential and sexually active males must use maximally effective birth control during the period of therapy and for 1 month after the last study drug infusion
- Not be pregnant or breastfeeding
- Not be HIV-positive
THE STUDY INVOLVES:
- Screening before the treatment, including lab tests and other assessments
- An intravesical (into the bladder) injections of the drug BC-819 with retention time of 30 minutes to 2 hours before bladder evacuation.
- Weekly treatments for a period, then treatments every 3 weeks for up to 84 more weeks.
- Response of the cancer to the treatment will be measured within the first 12 to 48 weeks of treatment.
- Regular followup will be required at intervals up to 96 weeks post the treatment
LOCATIONS AND CONTACTS:
The medical centers conducting this study are located in AZ, AK, CA, FL, ID, IL, KA, LA, MD, MI, MN, MO, NJ, NY, NC, OK, PA, SC, TN, TX, VA, and WV.
Contact: Sean T Daly | 857-277-5577 | [email protected]
Anchiano Therapeutics Israel Ltd.
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