A Phase Ib/II, Dose Expansion, Open-label Study to Evaluate Safety and Efficacy, of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Study Identifier:
TARA-002-101-PH2
CT.gov Identifier:
NCT05951179
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2023-505062-28-00
Study Contact Information:
N/A
Recruiting

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Study Summary

TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).

The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).

This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF.

Participants will be enrolled into one of 2 cohorts:

Cohort A:

Participants with CIS (± Ta/T1) who are BCG naive, or

Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis

Cohort B:

Participants who are BCG unresponsive

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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 CIS (± Ta/T1) who are BCG unresponsive.
    Exclusion criteria
    • Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
    • Central confirmed variant histology
    • 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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Abhishek Srivastava
    Status
    Recruiting
    Condition(s) Treated at Site
    Bladder