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

NCT05085977 | Completed Phase 1 FDA Drug

• 1 other identifier: TARA-002-101 (Phase 1a)
• Study Type: interventional
• Target: 12
• Locations: 4 countries
• Sites: 14

Brief Summary

This study is an open-label dose escalation study (Phase 1a) 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. Dosing will start in subjects with HGTa or CIS (including CIS with concomitant Ta), and all subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.

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 (2)

• Phase 1a, Dose Escalation Phase: Incidence of DLT AEs in subjects with HGTa or CIS NMIBC

  DLT = dose limiting toxicities; HGTa = high grade Ta; CIS = carcinoma in situ, includes CIS with concomitant Ta

  Day 1 to Day 43

• Phase 1a, Dose Escalation Phase: MTD and RP2D of TARA-002 in subjects with HGTa or CIS NMIBC

  MTD = maximum tolerated dose; RP2D = recommended Phase 2 dose

  Day 1 to Day 43

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 1a, Dose Escalation: First, up to 3 dose levels of TARA-002 (10 KE → 20 KE → 40 KE) will be tested sequentially with 6 weekly intravesical doses starting with the lowest dose using a 3+3 design in a dose escalation manner until the RP2D has been established. If the MTD is not reached, additional cohorts of dose levels higher than 40 KE may be explored.

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 on central review
• Subjects who are treatment naïve, are 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 (14)

USC Norris Cancer Center

Los Angeles, California, 90089, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Tulane Medical Center

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

New Jersey Urology

Mount Laurel, New Jersey, 08054, 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

PMSI Republican Clinical Hospital "T. Mosneaga," ARENSIA Exploratory Medicine Phase I Unit

Chisinau, Moldova

Location

Spitalul Clinic de Nefrologie Carol Davila

Bucharest, 10731, Romania

Location

Arensia Kapitanivka

Kapitanivka, 08111, Ukraine

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First, up to 3 dose levels of TARA-002 (10 KE → 20 KE → 40 KE) will be tested sequentially with 6 weekly intravesical doses starting with the lowest dose using a 3+3 design in a dose escalation manner until the RP2D has been established. If the MTD is not reached, additional cohorts of dose levels higher than 40 KE may be explored.

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: March 10, 2022
• Primary Completion: September 3, 2024
• Study Completion: October 30, 2024
• Last Updated: January 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1); MO (1); US (11); RO (1)