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

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

Trial Details

NCT ID

NCT05951179

Phase

PHASE2

Sponsor

Protara Therapeutics

Status

RECRUITING

Cancer Type

Non-Muscle-Invasive Bladder Cancer

Interventions

TARA-002

Locations (sample)

Homewood, Alabama, United States|33.47177,-86.80082
Phoenix, Arizona, United States|33.44838,-112.07404
Queen Creek, Arizona, United States|33.24866,-111.6343
Little Rock, Arkansas, United States|34.74648,-92.28959
Bakersfield, California, United States|35.37329,-119.01871

Key Eligibility Criteria

Male or female participants 18 years of age or older at the time of signing informed consent
Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requireme…
Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most…

For full eligibility, visit ClinicalTrials.gov.

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