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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 1b)

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

Fase

Fase 1

Estado

Completado

Participantes

10

previstos

Centros

10

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 may 2023.

Qué mide

Phase 1b, Dose Expansion Phase: Incidence of AEs in subjects with CIS NMIBC with active disease (del registro, en inglés) (del dia 1 al dia 78)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is open-label dose expansion study 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. After completion of the dose escalation phase (Phase 1a) and after the RP2D has been established, the dose expansion phase (Phase 1b) will start enrollment of subjects with CIS NMIBC with active disease to further evaluate the safety and preliminary efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase. All subjects will receive 6 weeks of treatment at the established RP2D.

Más ensayos de TARA

Todos los de TARA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05085990), actualizada en ene 2025.