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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 requirements prior to study entry
• 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 recent CIS diagnosis (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive.

🚫 You may not be able to join if…

• Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
• Central confirmed variant histology
• Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
• Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
• Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history For more information on eligibility criteria, please contact the Sponsor

Where this trial is running

• Urology Centers of Alabama, Homewood, Alabama, United States
• Mayo Clinic, Phoenix, Arizona, United States
• East Valley Urology Center of Arizona, Queen Creek, Arizona, United States
• Arkansas Urology, Little Rock, Arkansas, United States
• Michael Oefelein Clinical Trials, Bakersfield, California, United States
• Urology Group of Southern California, Los Angeles, California, United States
• University of California Irvine Medical Center, Orange, California, United States
• Genesis Research, San Diego, California, United States
• Genesis Research LLC, Torrance, California, United States
• Colorado University - Anshutz, Aurora, Colorado, United States
• AdventHealth Medical Group Urology of Denver, Denver, Colorado, United States
• Advanced Urology, Lakewood, Colorado, United States

+ 59 more sites.

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05951179.