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

Non-muscle Invasive Bladder Cancer Clinical Trial

— ADVANCED-1  

Official title:

A Phase 1a/b Dose Finding, Open-label Study to Evaluate Safety and Toxicity of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05085990
• Other study ID #: TARA-002-101(Phase 1b)
• Status: Recruiting
• Phase: Phase 1
• Start date: May 8, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Protara Therapeutics
• Contact: Chief Scientific Operations Officer
• Phone: 16468440337
• Email: clinicaltrials[@]protaratx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin allergy testing prior to inclusion in the study)
• 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.

Related Conditions & MeSH terms

• Non-muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	Mayo Clinic	Jacksonville	Florida
United States	USC Norris Cancer Center	Los Angeles	California
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates PC	Nashville	Tennessee
United States	Tulane Medical Center (TMC) - Clinic/Outpatient Facility	New Orleans	Louisiana
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester, Department of Urology	Rochester	New York
United States	UT Health San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Protara Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1b, Dose Expansion Phase: Incidence of AEs in subjects with CIS NMIBC with active disease	AE = adverse event	Day 1 to Day 78