Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05951179

Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer — ADVANCED-2  

Non-muscle Invasive Bladder Cancer Clinical Trial

Official title:
A Phase 2, Open-Label Study to Evaluate the Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer

Clinical Trial Summary

TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity 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 anti-tumor activity 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 prior to signing 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 with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05951179
Study type Interventional
Source Protara Therapeutics
Contact Chief Scientific Operations Officer
Phone 16468440337
Email clinicaltrials@protaratx.com
Status Recruiting
Phase Phase 2
Start date September 15, 2023
Completion date August 2030
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04736394 - A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients Phase 3
Active, not recruiting NCT04943094 - Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
Not yet recruiting NCT06227065 - Precise Neoadjuvant Chemoresection of Low Grade NMIBC Phase 2
Completed NCT02969109 - Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer
Completed NCT01458847 - Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer Phase 1
Recruiting NCT03914794 - A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors Phase 2
Recruiting NCT05126472 - Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment Phase 1
Recruiting NCT04644835 - Low Energy Shock Wave Therapy and Non-Muscle Invasive Bladder Cancer N/A
Recruiting NCT06126796 - Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
Active, not recruiting NCT04100733 - Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor N/A
Recruiting NCT05085990 - Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer Phase 1
Recruiting NCT03560479 - A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer Phase 1/Phase 2
Terminated NCT01310803 - Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder Phase 3
Completed NCT03081858 - Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer Phase 1/Phase 2
Completed NCT04498702 - Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy Phase 2
Recruiting NCT05337397 - Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
Active, not recruiting NCT04490993 - Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients Phase 3
Recruiting NCT04859751 - Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer Phase 3
Recruiting NCT05672615 - Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Not yet recruiting NCT06245603 - A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer N/A