First Patient Dosed in Early-Phase Trial Investigating a New Drug for Bladder Cancer

The first patient has been dosed in the phase 1 ADVANCED-1 clinical trial, which is evaluating the novel drug TARA-002 for the treatment of patients with non-muscle invasive bladder cancer, according to Protara Therapeutics, Inc., the manufacturer of the drug.

“(Non-muscle invasive bladder cancer) is one of the most recurrent and difficult to treat cancers with very limited treatment options,” said Jesse Shefferman, CEO of Protara Therapeutics, in a statement.

The trial will be testing TARA-002 in patients with non-muscle invasive bladder cancer (cancer within the tissue lining of the bladder that has not spread into the muscles of the bladder) with high-grade carcinoma in situ and high-grade papillary tumors. Researchers plan on enrolling 18 patients in this phase of the study.

ADVANCED-1 will kick off with a dose-escalation phase of the trial, where researchers are hoping to find the optimal dose of the drug. Study participants will receive six weekly intravesical (direct-to-the-bladder) doses of TARA-002 while the researchers monitor for safety, tolerability and preliminary signs of cancer-fighting potential for the drug. The main goal is to determine a recommended dose for phase 2 of the trial.

“We are thrilled to have dosed the first patient in our phase 1 study in (non-muscle invasive bladder cancer) and look forward to exploring TARA-002’s full potential in this pressing area of high unmet need,” Shefferman said.

TARA-002 works by activating immune cells within the tumor, sparking a local inflammatory reaction that will destroy cancer cells. New treatments would be a welcomed addition to this patient population, which does not currently have many options.

“While bladder cancer is the sixth most common cancer in the United States today, with (non-muscle invasive bladder cancer) representing approximately 80% of diagnoses, treatment options for these patients remain limited,” said Dr. Edward M. Messing, a professor of Urology, Oncology and Pathology at the University of Rochester in New York, and a principal investigator for the study, said in a statement.

“There is an urgent need for new therapeutic interventions for these patients, as there continues to be an increase in recurrence, progression and an escalated number of patients needing cystectomies (which is surgery to remove the bladder),” Messing said.

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