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

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Mitoxantrone

Criteria

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.