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Study identifier: NCT05951179 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Non-muscle Invasive Bladder Cancer  ·  Sponsor: Protara Therapeutics

PhasePhase 2
Planned participants131
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Chief Scientific Operations Officer  ·  16468440337  ·  clinicaltrials@protaratx.com

Always discuss trial participation with your own doctor first.

Locations (71)

Urology Centers of AlabamaHomewood, Alabama, United StatesRecruiting
Mayo ClinicPhoenix, Arizona, United StatesRecruiting
East Valley Urology Center of ArizonaQueen Creek, Arizona, United StatesRecruiting
Arkansas UrologyLittle Rock, Arkansas, United StatesRecruiting
Michael Oefelein Clinical TrialsBakersfield, California, United StatesRecruiting
Urology Group of Southern CaliforniaLos Angeles, California, United StatesTerminated
University of California Irvine Medical CenterOrange, California, United StatesRecruiting
Genesis ResearchSan Diego, California, United StatesWithdrawn
Genesis Research LLCTorrance, California, United StatesRecruiting
Colorado University - AnshutzAurora, Colorado, United StatesRecruiting
AdventHealth Medical Group Urology of DenverDenver, Colorado, United StatesRecruiting
Advanced UrologyLakewood, Colorado, United StatesRecruiting

+ 59 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05951179