IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07106762Tipo: INTERVENTIONALInicio: 30 de sept de 2025Fin estimado: 18 de nov de 2033

Traducción no disponible, mostrando original

Resumen

A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have histologically confirmed advanced urothelial carcinoma.
Participants must be eligible to receive platinum-based chemotherapy.
Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.
Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.
Participants must have ≥ 1 measurable lesion per RECIST v1.1.
Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

Criterios de exclusión

Participants must not have platinum-based chemotherapy exposure within 12 months.
Participants must not have received \>2 prior regimens irrespective of the setting.
Participants must not have prior ADC therapy targeting EGFR or HER3.
Participants must not have prior therapy with topoisomerase 1 inhibitor.
Participants must not have active, untreated brain metastases.

Intervenciones

drug

Iza-bren

Specified dose on specified days

drug

Cisplatin

Specified dose on specified days

drug

Gemcitabine

Specified dose on specified days

drug

Carboplatin

Specified dose on specified days

Ubicaciones

Local Institution - 0028

CABA, Buenos Aires, Argentina

Site 0028

NOT_YET_RECRUITING

Local Institution - 0023

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site 0023

NOT_YET_RECRUITING

Local Institution - 0024

ABB, Buenos Aires F.D., Argentina

Site 0024

NOT_YET_RECRUITING

Local Institution - 0026

Buenos Aires, Buenos Aires F.D., Argentina

Site 0026

NOT_YET_RECRUITING

Local Institution - 0025

Córdoba, Argentina

Site 0025

NOT_YET_RECRUITING

Local Institution - 0027

Mendoza, Argentina

Site 0027

NOT_YET_RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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