Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1b)

NCT05085990 | Completed Phase 1 FDA Drug

• 1 other identifier: TARA-002-101(Phase 1b)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 10

Brief Summary

This study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy. After completion of the dose escalation phase (Phase 1a) and after the RP2D has been established, the dose expansion phase (Phase 1b) will start enrollment of subjects with CIS NMIBC with active disease to further evaluate the safety and preliminary efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase. All subjects will receive 6 weeks of treatment at the established RP2D.

Conditions

Non-muscle Invasive Bladder Cancer

Keywords

Non-muscle invasive bladder cancer; bladder cancer; high grade Ta; carcinoma in situ; high-grade NMIBC

Outcome Measures

Primary Outcomes (1)

• Phase 1b, Dose Expansion Phase: Incidence of AEs in subjects with CIS NMIBC with active disease

  AE = adverse event

  Day 1 to Day 78

Study Arms (1)

TARA-002

EXPERIMENTAL

TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.

Biological: TARA-002

Interventions

TARA-002 BIOLOGICAL

Phase 1b, Dose Expansion Phase: All subjects will receive 6 weekly doses of TARA-002 at the recommended Phase 2 dose (R2PD)

TARA-002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 18 years of age or older at the time of signing the informed consent
• Subjects who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
• Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with concomitant Ta) urothelial cell carcinoma of the bladder according to central review
• Subjects who are treatment naïve, unable to obtain intravesical BCG for the treatment of NMIBC, have received at least one dose of intravesical BCG, or at least one dose of intravesical chemotherapy

You may not qualify if:

• 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 involvement or metastatic disease that existed at any time (past or present disease)
• Bladder cancer stage ≥ T1 within the last 36 months according to central histology review
• Bladder cancer stage CIS with concomitant T1
• For more information on eligibility criteria, please contact the sponsor.

Sponsors & Collaborators

• Protara Therapeutics: lead

Study Sites (10)

USC Norris Cancer Center

Los Angeles, California, 90089, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Tulane Medical Center (TMC) - Clinic/Outpatient Facility

New Orleans, Louisiana, 70112, United States

Location

Chesapeake Urology Research Associates

Baltimore, Maryland, 21204, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12603, United States

Location

University of Rochester, Department of Urology

Rochester, New York, 14642, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Associates PC

Nashville, Tennessee, 37209, United States

Location

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Carcinoma in Situ

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Chief Scientific Operations Officer

  Protara Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will receive 6 weekly doses of TARA-002 at the recommended Phase 2 dose (R2PD)

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: May 8, 2023
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: January 27, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)