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TARA-002 · ADVANCED-2

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

Ensayo de Protara Therapeutics, Inc. en Non-muscle Invasive Bladder Cancer (del registro, en inglés).

Fase

Fase 2

Estado

Reclutando pacientes

Participantes

131

previstos

Centros

78

Fin del objetivo primario

oct 2031

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2023.

Qué mide

Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002 (del registro, en inglés) (del mes 3 al mes 60)

Cómo lo describe el promotor

En el documentoEn inglés, del registroTARA-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

Más ensayos de TARA

Todos los de TARA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05951179), actualizada en ago 2026.