Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Recruiting now · Phase 2
Conditions studied: Non-muscle Invasive Bladder Cancer
In brief
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
Key facts
- Study ID
- NCT05951179
- Run by
- Protara Therapeutics
- People needed
- 131
- Starts
- 2023-09-15
- Expected to finish
- 2032-03-01
- Last updated by the study team
- 2026-06-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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 it is running
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
- University of Rochester, Department of Urology — Rochester, New York, United States (enrolling)
- Michael Oefelein Clinical Trials — Bakersfield, California, United States (enrolling)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
- Urology Centers of Alabama — Homewood, Alabama, United States (enrolling)
- Arkansas Urology — Little Rock, Arkansas, United States (enrolling)
- Mayo Clinic — Phoenix, Arizona, United States (enrolling)
- Colorado University - Anshutz — Aurora, Colorado, United States (enrolling)
- AdventHealth Medical Group Urology of Denver — Denver, Colorado, United States (enrolling)
- East Valley Urology Center of Arizona — Queen Creek, Arizona, United States (enrolling)
- Urology Associates of Denver — Lone Tree, Colorado, United States (enrolling)
- University of California Irvine Medical Center — Orange, California, United States (enrolling)
- Mayo Clinic — Jacksonville, Florida, United States (enrolling)
- Comprehensive Urologic Care — Lake Barrington, Illinois, United States (enrolling)
- Southern Urology — Lafayette, Louisiana, United States (enrolling)
- Genesis Research LLC — Torrance, California, United States (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Minnesota Urology, Woodbury — Bloomington, Minnesota, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Renown Regional Medical Center — St Louis, Missouri, United States (enrolling)
- Specialty Clinic Research of St. Louis — St Louis, Missouri, United States (enrolling)
- Advanced Urology — Lakewood, Colorado, United States (enrolling)
- Laura & Isaac Perlmutter Cancer Center - NYU Langone Health — New York, New York, United States (enrolling)
- Conrad Person Clinic — Memphis, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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