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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085977
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
Protara Therapeutics

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) 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 NMIBC to include a minimum of 1 dosing cohort and a maximum of 3 total dosing cohorts. All subjects will receive 6 weeks of treatment at a fixed volume with varying doses levels.

Condition or disease Intervention/treatment Phase
Non-muscle Invasive Bladder Cancer Biological: TARA-002 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2022
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: TARA-002
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
Phase 1a, Dose Escalation: 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




Primary Outcome Measures :
  1. Phase 1a, Dose Escalation Phase: Incidence of DLT AEs in subjects with HGTa or CIS NMIBC [ Time Frame: Day 1 to Day 43 ]
    DLT = dose limiting toxicities; HGTa = high grade Ta; CIS = carcinoma in situ

  2. Phase 1a, Dose Escalation Phase: MTD and RP2D of TARA-002 in subjects with HGTa or CIS NMIBC [ Time Frame: Day 1 to Day 43 ]
    MTD = maximum tolerated dose; RP2D = recommended Phase 2 dose



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 urothelial cell carcinoma of the bladder according to American Joint Committee on Cancer staging and 2016 WHO/ISUP grading classification.
  • Subjects who 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

Exclusion Criteria:

  • Penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo sensitivity testing prior to inclusion in the study)
  • Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components
  • Prostatic involvement, upper tract urothelial carcinoma, nodal involvement, or metastatic disease
  • Bladder cancer stage ≥ T1 according to American Joint Committee on Cancer staging criteria
  • Bladder cancer stage CIS with concomitant T1

For more information on eligibility criteria, please contact the sponsor.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085977


Contacts
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Contact: Chief Scientific Operations Officer 16468440337 clinicaltrials@protaratx.com

Locations
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United States, Maryland
Chesapeake Urology Research Associates Recruiting
Hanover, Maryland, United States, 21076
Contact: Use Central Contact         
United States, New Jersey
New Jersey Urology Recruiting
Mount Laurel, New Jersey, United States, 08054
Contact: Use Central Contact         
United States, New York
University of Rochester, Department of Urology Recruiting
Rochester, New York, United States, 14642
Contact: Use Central Contact         
Sponsors and Collaborators
Protara Therapeutics
Investigators
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Study Director: Chief Scientific Operations Officer Protara Therapeutics
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Responsible Party: Protara Therapeutics
ClinicalTrials.gov Identifier: NCT05085977    
Other Study ID Numbers: TARA-002-101 (Phase 1a)
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: March 28, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Protara Therapeutics:
Non-muscle invasive bladder cancer
bladder cancer
high grade Ta
carcinoma in situ
high-grade NMIBC
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases