Grant: Project Grant

OBJECTIVES We have designed a new drug (STK-01) specifically for delivery into the bladder of patients with bladder cancer. Here we will test STK-10 for the first time in patients. The primary goal of the trial will be to demonstrate that the drug is safe and does not cause excessive side effects. The trial will also allow us to determine the optimal dose of the drug, and will provide the first clues about how well the drug works. The goal of this trial is to set the foundation for larger trials with STK-01 that will allow the drug to be used in routine clinical practice. BACKGROUND Drugs are delivered into the bladder of patients with non-muscle invasive bladder cancer (NMIBC) in order to reduce the risk of the cancer coming back or developing into a more threatening cancer. Current drugs have significant limitations and treatment failure is common. There is an urgent need for more effective therapies for NMIBC. STK-01 is a new drug that consists of a traditional chemotherapy agent, docetaxel, loaded into a sticky polymer. This structure enables docetaxel to stick to the inner surface of the bladder better, thereby increasing the time it stays in the bladder and the depth that it can penetrate into the bladder wall. We have shown that STK-01 slows tumor growth in animal models of bladder cancer. RESEARCH PLAN We will conduct a clinical trial of STK-01 in about 30 bladder cancer patients in two stages. First we will determine the maximum dose that can be given safely to patients as a single dose. We will then test multiple administrations of this maximum dose. This will establish the safety of multiple doses and provide an early sign of the effectiveness of the drug. IMPACT Bladder cancer is the 5th most common malignancy in Canada, but no new therapies have been established in at least two decades. Intravesical STK-01 promises to improve the therapy of NMIBC and thereby enhance patient quality of life, minimize treatment burden and reduce cost.