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

Description

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)

Conditions

Non-muscle Invasive Bladder Cancer

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Study Overview

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Study Details

Study overview

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)

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

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

Condition
Non-muscle Invasive Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Urology Group of Southern California, Los Angeles, California, United States, 90017

Orange

University of California Irvine Medical Center, Orange, California, United States, 92697

Lone Tree

Urology Associates of Denver, Lone Tree, Colorado, United States, 80124

Lafayette

Southern Urology, Lafayette, Louisiana, United States, 70508

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Garden City

AccuMed Research Associates, Garden City, New York, United States, 11530

Rochester

University of Rochester, Department of Urology, Rochester, New York, United States, 14642

Myrtle Beach

Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States, 29572

Memphis

Conrad Person Clinic, Memphis, Tennessee, United States, 38128

Nashville

Urology Associates PC, Nashville, Tennessee, United States, 37209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (Cohort B).
  • * Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
  • * Predominant (defined as \> 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Protara Therapeutics,

Chief Scientific Operations Officer, STUDY_DIRECTOR, Protara Therapeutics

Study Record Dates

2030-08