Condition: Non-muscle Invasive Bladder Cancer · Sponsor: Protara Therapeutics
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.
Chief Scientific Operations Officer · 16468440337 · clinicaltrials@protaratx.com
Always discuss trial participation with your own doctor first.
| Urology Centers of Alabama | Homewood, Alabama, United States | Recruiting |
| Mayo Clinic | Phoenix, Arizona, United States | Recruiting |
| East Valley Urology Center of Arizona | Queen Creek, Arizona, United States | Recruiting |
| Arkansas Urology | Little Rock, Arkansas, United States | Recruiting |
| Michael Oefelein Clinical Trials | Bakersfield, California, United States | Recruiting |
| Urology Group of Southern California | Los Angeles, California, United States | Terminated |
| University of California Irvine Medical Center | Orange, California, United States | Recruiting |
| Genesis Research | San Diego, California, United States | Withdrawn |
| Genesis Research LLC | Torrance, California, United States | Recruiting |
| Colorado University - Anshutz | Aurora, Colorado, United States | Recruiting |
| AdventHealth Medical Group Urology of Denver | Denver, Colorado, United States | Recruiting |
| Advanced Urology | Lakewood, Colorado, United States | Recruiting |
+ 59 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05951179