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Active (not recruiting) Phase 2 NCT06679985

A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma

Phase 2 – studying effectiveness and dosage
Conditions: Hepatocellular Carcinoma

Sponsor: Coherus Oncology, Inc.

trial.available_in: БГ
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.
Who can participate
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.
Locations 6
Australia (1)
Royal Brisbane and Women's Hospital
Herston , Brisbane
Canada (1)
Sunnybrook Health Sciences Centre - Bayview Campus
Toronto , Ontario
Hong Kong (1)
Prince of Wales Hospital
Shatin , New Territories
Singapore (1)
National Cancer Centre Singapore
Singapore
Taiwan (1)
China Medical University Hospital
Taichung , Taichung City
United States (1)
Mayo Clinic - Scottsdale
Scottsdale , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.12.2024
Completion date
01.09.2027
Registry ID
NCT06679985
Source
anzctr
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