ReclutandoNCT07869836Registro de ClinicalTrials.gov

BL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy

Urothelial Cancer · Metastatic Urothelial Cancer · Bladder Cancer · Bladder Cancer (BC) · Bladder (Urothelial, Transitional Cell) Cancer · Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable · Bladder Ca · Bladder Cancer Recurrent · Bladder Cancer Stage IV · Urothelial Carcinoma Bladder · Urothelial Carcinoma Recurrent · Urothelial Carcinoma of the Urinary Bladder

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De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 3
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 520 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The objective of the study is to evaluate the efficacy and safety of T-bren in participants with HER2 expressing metastatic UC with progression on or after anti-PD-(L)1-based therapy.

Leer la descripción completa

This study is a Global Phase 3, randomized, open-label, multicenter study of T-bren for the treatment of metastatic UC. This study will assess the efficacy and safety of T-bren versus PBC in adult participants with HER2-expressing UC after progression on anti-PD-(L)1-based therapy.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Histologically or cytologically documented metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder, or urethra. Minor histologic variants (ie, \<50% overall) are acceptable, provided that TCC is the dominant histology.
Disease progression or recurrence during or following anti-PD-(L)1-based therapy.
Fresh biopsy or archival tumor samples.
Documented HER2 expression by central laboratory testing.
Eligible to receive carboplatin or cisplatin in combination with gemcitabine.
At least 1 measurable lesion based on RECIST v1.1.
An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
Adequate organ function.
Adequate coagulation parameters.

Exclusion Criteria:

Prior topoisomerase inhibitor-based ADC therapy.
Primary tumors in the central nervous system (CNS), active or untreated CNS metastases, or carcinomatous meningitis.
Bladder cancers with small cell histology.
Other prior or concurrent malignancies except for certain localized cancers or low-grade prostate cancer (if approved by sponsor), or other malignancy treated with curative intent with a disease-free interval of at least 3 years.
Prior history of clinically significant bleeding, or perforation of the gastrointestinal tract within 6 months of randomization.
Active autoimmune diseases and inflammatory diseases.
History of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Advanced/clinically significant lung disease (eg, poorly controlled chronic obstructive pulmonary disease or asthma, restrictive lung disease, or pulmonary hypertension) within 6 months prior to randomization.
Known human immunodeficiency virus infection.
Active hepatitis B virus (HBV) infection.
Active hepatitis C virus (HCV) infection.
Active or latent tuberculosis.
Other protocol-specified inclusion/ exclusion criteria apply

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento simple

Arm A, T-bren Dose Level 1

T-bren administered intravenously

Drug: T-Bren, Dose level 1

Arm B, T-bren Dose Level 2

T-bren administered intravenously

Drug: T-bren, Dose level 2

Arm C, Control Arm, Platinum-based Chemotherapy (PBC)

1. Gemcitabine Administered intravenously
2. Cisplatin or Carboplatin Administered intravenously

Drug: Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)

T-Bren, Dose level 1 DRUG

T-bren: Administered intravenously on day 1 of each 21-day cycle

T-bren, Dose level 2 DRUG

TBren administered intravenously on day 1 of each 21-day cycle

Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin) DRUG

Gemcitabine administered intravenously on Day 1 and Day 8 of each 21-day cycle and Cisplatin or Carboplatin administered intravenously on Day 1 of each 21-day cycle

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