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Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer — ADVANCED-1  

Non-muscle Invasive Bladder Cancer Clinical Trial

Official title:
A Phase 1a/b Dose Finding, Open-label Study to Evaluate Safety and Toxicity of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Clinical Trial Summary

This study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy. After completion of the dose escalation phase (Phase 1a) and after the RP2D has been established, the dose expansion phase (Phase 1b) will start enrollment of subjects with CIS NMIBC with active disease to further evaluate the safety and preliminary efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase. All subjects will receive 6 weeks of treatment at the established RP2D.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05085990
Study type Interventional
Source Protara Therapeutics
Contact Chief Scientific Operations Officer
Phone 16468440337
Email clinicaltrials@protaratx.com
Status Recruiting
Phase Phase 1
Start date May 8, 2023
Completion date August 2024
View Details
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