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Dose Expansion, Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer — ADVANCED-2  

Non-muscle Invasive Bladder Cancer Clinical Trial

Official title:
A Phase 1b/2, Dose Expansion, Open-label Study to Evaluate Safety and Anti-tumor Activity, of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Clinical Trial Summary

TARA-002-101-Ph1b/2 is an open-label Phase 1b/2 dose expansion study to investigate the safety and anti-tumor activity of intravesical treatment of high-grade CIS NMIBC (± Ta/T1) with intravesical instillation of TARA-002 in adults 18 years of age or older. The Phase 1b/2 study (TARA-002-101-Ph1b/2) will be initiated after the RP2D has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 1b/2 (TARA-002-101-Ph1b/2) dose expansion study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: Cohort A: - Participants with CIS (± Ta/T1) who are unable to obtain intravesical BCG, or - Participants with CIS (± Ta/T1) who have not received intravesical BCG for 24 months prior to CIS diagnosis Cohort B: - Participants with CIS (± Ta/T1) who are BCG unresponsive after completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05951179
Study type Interventional
Source Protara Therapeutics
Contact Chief Scientific Operations Officer
Phone 16468440337
Email clinicaltrials@protaratx.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 15, 2023
Completion date August 2026
View Details
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