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

Primary Purpose

Non-muscle Invasive Bladder Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TARA-002
Sponsored by
Protara Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-muscle Invasive Bladder Cancer focused on measuring Non-muscle invasive bladder cancer, bladder cancer, high grade Ta, carcinoma in situ, high-grade NMIBC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC Norris Cancer CenterRecruiting
  • Mayo ClinicRecruiting
  • Tulane Medical Center (TMC) - Clinic/Outpatient FacilityRecruiting
  • Chesapeake Urology Research Associates
  • Mayo ClinicRecruiting
  • Premier Medical Group of the Hudson Valley
  • University of Rochester, Department of UrologyRecruiting
  • Carolina Urologic Research CenterRecruiting
  • Urology Associates PC
  • UT Health San AntonioRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TARA-002

Arm Description

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

Outcomes

Primary Outcome Measures

Phase 1b, Dose Expansion Phase: Incidence of AEs in subjects with CIS NMIBC with active disease
AE = adverse event

Secondary Outcome Measures

Full Information

First Posted
October 7, 2021
Last Updated
August 16, 2023
Sponsor
Protara Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05085990
Brief Title
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protara Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 consomitant 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-muscle Invasive Bladder Cancer
Keywords
Non-muscle invasive bladder cancer, bladder cancer, high grade Ta, carcinoma in situ, high-grade NMIBC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive 6 weekly doses of TARA-002 at the recommended Phase 2 dose (R2PD)
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TARA-002
Arm Type
Experimental
Arm Description
TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.
Intervention Type
Biological
Intervention Name(s)
TARA-002
Intervention Description
Phase 1b, Dose Expansion Phase: All subjects will receive 6 weekly doses of TARA-002 at the recommended Phase 2 dose (R2PD)
Primary Outcome Measure Information:
Title
Phase 1b, Dose Expansion Phase: Incidence of AEs in subjects with CIS NMIBC with active disease
Description
AE = adverse event
Time Frame
Day 1 to Day 78

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Scientific Operations Officer
Phone
16468440337
Email
clinicaltrials@protaratx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Scientific Operations Officer
Organizational Affiliation
Protara Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
USC Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Tulane Medical Center (TMC) - Clinic/Outpatient Facility
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Completed
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Individual Site Status
Completed
Facility Name
University of Rochester, Department of Urology
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Urology Associates PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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