Resumen del Estudio
Este estudio clínico, parte de la plataforma LIGHTBEAM, tiene como objetivo evaluar una terapia innovadora llamada Zilovertamab vedotin en pacientes pediátricos y adultos jóvenes. Está diseñado para aquellos que padecen ciertos tipos de cáncer de la sangre (como leucemia B-ALL o linfomas) o tumores sólidos (neuroblastoma y sarcoma de Ewing) y que, lamentablemente, han recaído o no han respondido a los tratamientos convencionales. El Zilovertamab vedotin es un conjugado anticuerpo-fármaco, una tecnología que busca atacar selectivamente a las células cancerosas minimizando el daño a las células sanas. Durante el estudio, los médicos vigilarán estrictamente la seguridad del medicamento, su tolerabilidad y si logra reducir o eliminar el cáncer (respuesta objetiva) en estos pacientes que necesitan nuevas opciones terapéuticas.
Criterios de Elegibilidad
Resumen de Elegibilidad:Criterios de inclusión: Niños y jóvenes con diagnóstico confirmado de Leucemia (B-ALL), Linfoma (DLBCL/Burkitt), Neuroblastoma o Sarcoma de Ewing que sea recurrente o refractario. Criterios de exclusión: Antecedentes de trasplante de órganos sólidos, enfermedad cardiovascular activa, cirrosis hepática conocida, infecciones activas por Hepatitis B, C o VIH, o neuropatía grave.
- For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.
- For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.
- History of solid organ transplant.
- Clinically significant (ie, active) cardiovascular disease.
- Known history of liver cirrhosis.
- Ongoing Grade \>1 peripheral neuropathy.
- Demyelinating form of Charcot-Marie-Tooth disease.
- Diagnosed with Down syndrome.
- Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.
- History of human immunodeficiency virus (HIV) infection.
- Contraindication or hypersensitivity to any of the study intervention components.
- Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.
- Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).
- Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- Known additional malignancy that is progressing or has required active treatment within the past 1 year.
- Active infection requiring systemic therapy.
- Known history of Hepatitis B or known active Hepatitis C virus infection.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.