A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
Sponsor: Coherus Biosciences, Inc.
ClinicalTrials ID:NCT06679985
This clinical trial evaluates the safety and efficacy of casdozokitug with toripalimab and bevacizumab in patients with unresectable or metastatic hepatocellular carcinoma. Eligible participants must have histologically or clinically confirmed advanced HCC, not suitable for curative therapies, and possess at least one measurable lesion. The study aims to establish a recommended dose for the drug combination.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| Sarcoma Oncology Center | 90403 | Santa Monica | California |
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