A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC
Phase 1
- Conditions
- Advanced Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT04331743
- Lead Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PLM60 Liposome-entrapped Mitoxantrone Hydrochloride Injection 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).
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) 1 year To identify the maximum tolerated dose (MTD).
Dose-limited toxicity (DLT) 1year To identify the dose-limited toxicity (DLT).
Recommended Phase II Dose (RP2D) 1 year To identify the Recommended Phase II Dose (RP2D)
- Secondary Outcome Measures
Name Time Method Median overall survival (OS) 2 years To preliminarily evaluate ORR in patients with advanced HCC.
Median progression free survival (PFS) 2 years To preliminarily evaluate PFS in patients with advanced HCC.
Overall response rate (ORR) 2 years To preliminarily evaluate ORR in patients with advanced HCC.
Time of peak plasma concentration (Tmax) 2 years To preliminarily evaluate Tmax in patients with advanced HCC.
Area under the plasma concentration versus time curve (AUC) 2 years To preliminarily evaluate the AUC in patients with advanced HCC.
Peak Plasma Concentration (Cmax) 2 years To preliminarily evaluate Cmax in patients with advanced HCC.
Duration of Response (DoR) 2 years To preliminarily evaluate DoR in patients with advanced HCC.