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TARA-002 · ADVANCED-1

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

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

Fase

Fase 1

Estado

Completado

Participantes

12

previstos

Centros

14

Fin del objetivo primario

sep 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2022.

Qué mide

Phase 1a, Dose Escalation Phase: Incidence of DLT AEs in subjects with HGTa or CIS NMIBC (del registro, en inglés) (del dia 1 al dia 43)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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, including CIS with concomitant Ta) 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 (including CIS with concomitant Ta), and all subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.

Más ensayos de TARA

Todos los de TARA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05085977), actualizada en ene 2025.