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Cretostimogene Grenadenorepvec · BOND-003

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

Ensayo de CG Oncology, Inc. en Cancer de vejiga no musculoinvasivo · Enfermedad papilar Ta/T1 de alto grado del cancer de vejiga.

Fase

Fase 3

Estado

En marcha, sin reclutar

Participantes

190

previstos

Centros

86

Fin del objetivo primario

jun 2030

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en oct 2020.

Qué mide

Cohorte C: (36 meses)

Qué se prueba

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment. Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC

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Todos los de CGON, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04452591), actualizada en jul 2026.