Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma

Exclusion Criteria

• •Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
• •Previously received an anti-interleukin (IL)-27 antibody (Ab) or anti-IL-27-targeted therapy.
• •Received prior systemic therapy for unresectable or metastatic disease. (Note: Prior systemic therapies administered for neoadjuvant, adjuvant, or curative intent (localized disease) are permitted if they were given \> 1 year prior to the development of recurrent or metastatic disease)
• •Known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• •Moderate or severe ascites
• •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• •History of or current hepatic encephalopathy
• •Unable to undergo disease evaluation with a triphasic CT or MRI because of contrast allergy or other contraindication
• •Untreated or incompletely treated varices with bleeding or high risk for bleeding.
• •Symptomatic or untreated brain metastases or leptomeningeal carcinomatosis.
• •Active or history of autoimmune disease or immune deficiency with some exceptions such as controlled thyroid disease, Type 1 diabetes, eczema and other minor skin disorders.
• •Medical conditions requiring chronic steroid therapy (ie, \> 10 mg/day of prednisone or its equivalent) or anticipates the need for systemic immunosuppressive medications during treatment with study drug
• •Known active infection with HIV
• •Known infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), except for controlled active HBV or fully treated HCV infection as defined by the protocol
• •Inadequately controlled arterial hypertension