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

A Single-arm, Open-label, Single-center Phase Ib Study to Evaluate the Safety and Efficacy of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Advanced Hepatocellular Carcinoma (HCC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Liposome-entrapped Mitoxantrone Hydrochloride Injection

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kun Lou; Phone Number: 0311-67808817; Email: loukun@mail.ecspc.com
• Study Contact Backup: Name: Xuefang Xia; Phone Number: 010-63930702; Email: xiaxuefang@mail.ecspc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: PLM60

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose (MTD)	To identify the maximum tolerated dose (MTD).	1 year
Dose-limited toxicity (DLT)	To identify the dose-limited toxicity (DLT).	1year
Recommended Phase II Dose (RP2D)	To identify the Recommended Phase II Dose (RP2D)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC)	To preliminarily evaluate the AUC in patients with advanced HCC.	2 years
Peak Plasma Concentration (Cmax)	To preliminarily evaluate Cmax in patients with advanced HCC.	2 years
Time of peak plasma concentration (Tmax)	To preliminarily evaluate Tmax in patients with advanced HCC.	2 years
Median overall survival (OS)	To preliminarily evaluate ORR in patients with advanced HCC.	2 years
Median progression free survival (PFS)	To preliminarily evaluate PFS in patients with advanced HCC.	2 years
Overall response rate (ORR)	To preliminarily evaluate ORR in patients with advanced HCC.	2 years
Duration of Response (DoR)	To preliminarily evaluate DoR in patients with advanced HCC.	2 years

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 5, 2021
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Mitoxantrone
• Other Study ID Numbers: PLM60-HCC-201901/PRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No