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Active Not Recruiting
NCT06679985
A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
Conditions: Hepatocellular Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 72
Sponsor: Coherus Oncology, Inc.
Location: Mayo Clinic - Scottsdale Scottsdale Arizona
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 Criteria
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.
Source: ClinicalTrials.gov (NCT06679985). StuddyBuddy aggregates publicly available trial information.
