RecruitingPhase 2NCT06679985
A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
A Randomized Phase 2 Study of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
Sponsor
Coherus Oncology, Inc.
Enrollment
72 participants
Start Date
Dec 20, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria5
- 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).
Interventions
DRUGBevacizumab
Solution for infusion
DRUGCasdozokitug
Solution for infusion
DRUGToripalimab
Solution for infusion
Locations(44)
View Full Details on ClinicalTrials.gov
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NCT06679985
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