Tests TARA-002 given into the bladder for high-grade bladder cancer
Tests TARA-002, given into the bladder, in adults with early high-grade bladder cancer.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Key facts
- Where
- Campinas, Jardim Paulista, Nova Lima, Porto Alegre, and Santo André, BrazilSee the 8 sites
- Phase
- Phase 2
Where in Brazil
- Hospital de Clínicas da UNICAMPCampinas, BrazilTaking people
- Instituto Dor de Pesquisa e EnsinoJardim Paulista, BrazilTaking people
- Kyushu University HospitalNova Lima, BrazilTaking people
- Office of Lucas Nougeria MANova Lima, BrazilTaking people
- Centro de Urologia AvancadaPorto Alegre, BrazilTaking people
- Nucleo de Pesquisa Clinica do Rio Grande so SulPorto Alegre, BrazilTaking people
- Santa Casa de Misericordia de Porto AlegrePorto Alegre, BrazilTaking people
- Faculdade de Medicina ABC-CEPHOSanto André, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Protara Therapeutics
- Trial code
- NCT05951179
- Record updated
- 24 August 2026
- Original description
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).Read full original descriptionShow less
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer
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
Inclusion: 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: 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; Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory; Central confirmed variant histology.