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

CSPC Pharmaceutical Group

Status and phase: Unknown; Phase 1

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Drug: Liposome-entrapped Mitoxantrone Hydrochloride Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04331743

PLM60-HCC-201901/PRO

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

PLM60

Experimental group

Description:

Three dose levels will be tested according to the "3 + 3" dose-escalation design.The dose-limiting toxicity (DLT) will be assessed from the first administration of PLM60 to the end of the first cycle (28 days).

Treatment:

Drug: Liposome-entrapped Mitoxantrone Hydrochloride Injection