Summary

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.

Age: 18 Years and older

Gender: All

Start Date: 12/20/2024

Primary Completion Date (Estimated): 09/01/2027

Study Completion Date (Estimated): 09/01/2027

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

Key inclusion criteria:

* 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.

Exclusion criteria:

* 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.