Liver Cancer Clinical Trials

• Age 18+ (20+ for subjects in Taiwan)

• Diagnosis of hepatocellular carcinoma

‣ Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion)

• Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab).

• Barcelona Clinic Liver Cancer (BCLC) stage B not appropriate for or with disease progression after local regional therapy, or BCLC stage C

• Child-Pugh liver function class A

• Measurable disease (per mRECIST)

• ECOG performance status of 0 to 1

• Adequate laboratory parameters including:

‣ AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement)

⁃ Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome)

⁃ ANC ≥1500/µL

⁃ Platelets ≥ 90,000/µL

⁃ HGB ≥ 9.0 g/dL

⁃ Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula

⁃ Serum albumin ≥ 2.8 gm/dL

⁃ INR ≤ 2.3

⁃ PT/aPTT ≤ 1.2 x ULN

• QTcF ≤ 480 msec

• Subjects are eligible to enroll if they have HBV-, or HCV-HCC, defined as follows:

‣ Chronic HBV infection as evidenced by detectable HBV DNA or HBsAg. Subjects with chronic HBV infection must be on antiviral therapy and have HBV DNA \<500 IU/mL. If not on an antiviral therapy at screening, then subjects must be willing to start the antiviral therapy at the time of consent.

⁃ Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody.