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

NCT ID: NCT04331743

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-05
• Study Completion Date: 2023-06-01

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.

Conditions

Advanced Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Liposome-entrapped Mitoxantrone Hydrochloride Injection

Intervention Type: DRUG

Intravenous infusion

Interventions

Liposome-entrapped Mitoxantrone Hydrochloride Injection

Intravenous infusion

Intervention Type: DRUG

Other Intervention Names

PLM60

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Kun Lou

Role: CONTACT

loukun@mail.ecspc.com

0311-67808817

Xuefang Xia

Role: CONTACT

xiaxuefang@mail.ecspc.com

010-63930702

Other Identifiers

PLM60-HCC-201901/PRO

Identifier Type: -

Identifier Source: org_study_id