Bladder Cancer Clinical Trial

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

Summary

TARA-002-101-Ph1b/2 is an open-label Phase 1b/2 dose expansion study to investigate the safety and anti-tumor activity of intravesical treatment of high-grade CIS NMIBC (± Ta/T1) with intravesical instillation of TARA-002 in adults 18 years of age or older.

The Phase 1b/2 study (TARA-002-101-Ph1b/2) will be initiated after the RP2D has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).

This Phase 1b/2 (TARA-002-101-Ph1b/2) dose expansion study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF).

Participants will be enrolled into one of 2 cohorts:

Cohort A:

Participants with CIS (± Ta/T1) who are unable to obtain intravesical BCG, or
Participants with CIS (± Ta/T1) who have not received intravesical BCG for 24 months prior to CIS diagnosis

Cohort B:

Participants with CIS (± Ta/T1) who are BCG unresponsive after completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female participants 18 years of age or older at the time of signing informed consent
Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (Cohort B).

Exclusion Criteria:

Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
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 and metastatic disease are excluded if they existed at any time (whether present or in the past)
Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history

For more information on eligibility criteria, please contact the Sponsor

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

127

Study ID:

NCT05951179

Recruitment Status:

Recruiting

Sponsor:

Protara Therapeutics

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There are 10 Locations for this study

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Urology Group of Southern California
Los Angeles California, 90017, United States More Info
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Brigham and Women's Hospital
Boston Massachusetts, 02115, United States More Info
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AccuMed Research Associates
Garden City New York, 11530, United States More Info
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University of Rochester, Department of Urology
Rochester New York, 14642, United States More Info
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Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
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Urology Associates PC
Nashville Tennessee, 37209, United States More Info
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Urology Austin, LLC
Austin Texas, 78745, United States More Info
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Clinical Trial Network
Houston Texas, 77074, United States More Info
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Virginia Urology
Richmond Virginia, 23235, United States More Info
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Arensia Kapitanivka - PPDS
Kapitanivka , 08111, Ukraine More Info
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How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

127

Study ID:

NCT05951179

Recruitment Status:

Recruiting

Sponsor:


Protara Therapeutics

How clear is this clinincal trial information?

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