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RECRUITING Phase 2

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

NCT05951179 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

  • BIOLOGICAL TARA-002

Study Locations (20)

California

  • Michael Oefelein Clinical Trials — Bakersfield
  • Urology Group of Southern California — Los Angeles
  • University of California Irvine Medical Center — Orange
  • Genesis Research — San Diego
  • Genesis Research LLC — Torrance

Colorado

  • Colorado University - Anshutz — Aurora
  • AdventHealth Medical Group Urology of Denver — Denver
  • Advanced Urology — Lakewood
  • Urology Associates of Denver — Lone Tree

Arizona

  • Mayo Clinic — Phoenix
  • East Valley Urology Center of Arizona — Queen Creek

Florida

  • University of Florida Health Jacksonville — Gainesville
  • Mayo Clinic — Jacksonville

Louisiana

  • Southern Urology — Lafayette
  • Ochsner Health LSU - Regional Urology — Shreveport

Alabama

  • Urology Centers of Alabama — Homewood

Arkansas

  • Arkansas Urology — Little Rock

Illinois

  • Comprehensive Urologic Care — Lake Barrington

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2023-09-15
Est. Completion 2030-08
Phase Phase 2

Sponsor

Protara Therapeutics

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05951179

The ClinicalTrials.gov registry entry for NCT05951179 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protara Therapeutics, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 1 intervention — of which TARA-002 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05951179 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05951179 about?

NCT05951179 is a clinical study titled "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-0...

What is the current status of trial NCT05951179?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2023-09-15. Estimated completion is 2030-08.

What conditions does trial NCT05951179 study?

This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05951179?

The interventions under investigation include: TARA-002 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05951179?

This trial is sponsored by Protara Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05951179 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial