A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: PLM60 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). |
Drug: Liposome-entrapped Mitoxantrone Hydrochloride Injection
Intravenous infusion
Other Names:
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Outcome Measures
Primary Outcome Measures
- Dose-limited toxicity (DLT) [1year]
To identify the dose-limited toxicity (DLT).
- Maximum tolerated dose (MTD) [1 year]
To identify the maximum tolerated dose (MTD).
- Recommended Phase II Dose (RP2D) [1 year]
To identify the Recommended Phase II Dose (RP2D)
Secondary Outcome Measures
- 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.
- Time of peak plasma concentration (Tmax) [2 years]
To preliminarily evaluate Tmax in patients with advanced HCC.
- 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.
- Duration of Response (DoR) [2 years]
To preliminarily evaluate DoR in patients with advanced HCC.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent from the patient;
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ECOG performance status of 0 or 1;
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Histologically/cytologically confirmed diagnosis of advanced HCC;
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Adequate washout period for previous anti-tumor therapy;
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Measurable disease according to RECIST v1.1;
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Life expectancy ≥ 12 weeks;
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Adequate organ function;
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Child-Pugh grade A or partial grade B; BCLC stage B or C;V
Exclusion Criteria:
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Prior treatment with Mitoxantrone or Liposome-entrapped Mitoxantrone, or other anthracyclines, with the total cumulative dose of > 360 mg/m2 ;
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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;
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Active central nervous system (CNS) metastases (brain or leptomeningeal metastases, etc.);
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Any history of other malignancy within 5 years;
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Untreated hepatitis infection;
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HIV positive;
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History of liver transplantation, severe cirrhosis, hepatic encephalopathy;
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Inadequate cardiac function;
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Pregnant or lactating women.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLM60-HCC-201901/PRO