NCT05951179

Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (estimated)
• Sponsor: Protara Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF. Participants will be enrolled into one of 2 cohorts: Cohort A: * Participants with CIS (± Ta/T1) who are BCG naive, or * Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: * Participants who are BCG unresponsive

Conditions

• Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	TARA-002	All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15, and 18. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 21 until Month 60.

Timeline

• Start date: 2023-09-15
• Primary completion: 2030-05-01
• Completion: 2030-08-01
• First posted: 2023-07-18
• Last updated: 2026-01-27

Locations

61 sites across 6 countries: United States, Argentina, Brazil, Canada, Japan, Ukraine

Regulatory

• FDA-regulated drug study