Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)

A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy

The purpose of this study is to assess efficacy and safety in combination of resminostat and sorafenib in Asian patients with advanced HCC previously untreated with systemic chemotherapy.

Main Inclusion Criteria:

• Patients with advanced or metastatic hepatocellular carcinoma
• Patients with ECOG PS of 0-1
• Patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications

Main Exclusion Criteria:

• Patients with a history of treatment with HDAC inhibitors
• Pregnant women and lactating mothers
• Patients with brain metastases or suspected brain metastases based on the clinical symptoms