Resumen

The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.

Edad: 18 años o más

Género: Todos

Fecha de inicio: 12/20/2024

Fecha de finalización principal (estimada): 09/01/2027

Fecha estimada de finalización del estudio: 09/01/2027

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

Criterios de elegibilidad

Edad: 18 años o más

Género: Todos

Acepta voluntarios sanos: No

Criterios clave de inclusión:

* Unresectable locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic participants.

* Disease that is not amenable to curative surgical and/or locoregional therapies or progressive disease (PD) after surgical and/or locoregional therapies.

* ≥ 1 measurable lesion (per RECIST v1.1) that is untreated.

Criterios de exclusión:

* Has received prior systemic therapy for HCC.

* Has previously received an anti-IL-27 antibody (Ab) or anti-IL-27-targeted therapy.

* Has known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

* Has moderate or severe ascites.

* Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).

Additional protocol-defined inclusion/exclusion criteria apply.