Un ensayo clínico abierto y aleatorizado sobre la eficacia y seguridad de zanidatamab combinado con el tratamiento estándar frente al tratamiento estándar solo en el cáncer de vías biliares avanzado HER2 positivo

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06282575Tipo: INTERVENTIONALInicio: 19 de jul de 2024Fin estimado: 1 de abr de 2030

Resumen

El propósito de este estudio es evaluar la eficacia y seguridad de zanidatamab más CisGem (cisplatino y gemcitabina) con o sin la adición de un inhibidor de la proteína de muerte celular programada 1/ligando 1 (PD-1/L1) (a elección del médico: durvalumab o pembrolizumab, donde esté aprobado según las regulaciones locales) como primera línea de tratamiento para participantes con cáncer de vías biliares HER2 positivo (receptor 2 del factor de crecimiento epidérmico humano).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).
Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
Received no more than 2 cycles of systemic therapy which is limited to Cisplatin and Gemcitabine (CisGem) with or without a PD-1/L1 inhibitor (physician's choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease.
HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy.
Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function
Females of childbearing potential must have a negative pregnancy test result.
Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Criterios de exclusión

Prior treatment with a HER2-targeted agent
Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region.
Use of systemic corticosteroids.
Brain metastases
Severe chronic or active infections
History of allogeneic organ transplantation.
Active or prior autoimmune inflammatory conditions
History of interstitial lung disease or non-infectious pneumonitis.
Participation in another clinical trial with an investigational medicinal product within the last 3 months.
Females who are breastfeeding
Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
Use of phenytoin