First Bladder Cancer Patients Dosed in Protara Therapeutics Phase Ib Trial

Anna Osborne
16 May 2023
Cell Therapy
Clinical Trials
Regulatory & Standards
Clinical-stage developer of cancer and rare disease therapies Protara Therapeutics has announced the initiation of patient dosing in its Phase Ib trial evaluating TARA-002, an investigational cell-based therapy, in patients with high-grade non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS).

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of diagnoses.

TARA-002 is an investigational cell therapy developed for the treatment of NMIBC. It activates innate and adaptive immune cells within the bladder, triggering a strong immune response to destroy abnormal cells.

Positive preliminary results from the Phase Ia dose-escalation component of the ADVANCED-1 trial were presented at the at the American Urological Association Annual Meeting in April 2023.

The data demonstrated that TARA-002 was well tolerated, and anti-tumor activity was observed, including tumor regression in patients with CIS.

The ADVANCED-1 expansion Phase Ib trial will assess the safety, tolerability, and anti-tumor activity of TARA-002 in 12 CIS patients who are BCG-naïve, BCG-unresponsive, or inadequately treated.

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Trial participants will receive six once-weekly intravesical instillations of TARA-002 at the 40KE1 dose.

The primary endpoint of the trial is the complete response rate at three months.

Based on these results, Protara plans to initiate ADVANCED-2, a Phase Ib/2 trial, to further evaluate TARA-002 in up to 102 patients with CIS, in the second half of 2023.

“We believe TARA-002 has the potential to play a meaningful role in the NMIBC treatment landscape, as there continues to be limited treatment options for this highly recurrent disease,” commented Jathin Bandari, Chief Medical Officer of Protara Therapeutics. “We look forward to gaining additional clinical experience with TARA-002 in NMIBC patients with CIS,” he adds.

Source: Protara Press Release

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