A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC

A Single-arm, Open-label, Single-center Phase Ib Study to Evaluate the Safety and Efficacy of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Advanced Hepatocellular Carcinoma (HCC)

This is a dose escalation study based on 3+3 design with the aim to establish MTD and provide RP2D. PLM60 is to administered by multi-cycle intravenous infusion.

Inclusion Criteria:

• Signed informed consent from the patient；
• ECOG performance status of 0 or 1;
• Histologically/cytologically confirmed diagnosis of advanced HCC;
• Adequate washout period for previous anti-tumor therapy;
• Measurable disease according to RECIST v1.1;
• Life expectancy ≥ 12 weeks;
• Adequate organ function;
• Child-Pugh grade A or partial grade B; BCLC stage B or C;V

Exclusion Criteria:

• Prior treatment with Mitoxantrone or Liposome-entrapped Mitoxantrone, or other anthracyclines, with the total cumulative dose of > 360 mg/m2 ;
• Any drug-related adverse event derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects, that has not recovered to grade1 or less;
• Active central nervous system (CNS) metastases (brain or leptomeningeal metastases, etc.);
• Any history of other malignancy within 5 years;
• Untreated hepatitis infection;
• HIV positive;
• History of liver transplantation, severe cirrhosis, hepatic encephalopathy;
• Inadequate cardiac function;
• Pregnant or lactating women.