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)

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04331743

Enrollment

Registered

2020-04-02

Start date

2021-06-05

Completion date

2023-06-01

Last updated

2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma

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.

Interventions

DRUGLiposome-entrapped Mitoxantrone Hydrochloride Injection

Intravenous infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactKun Lou

loukun@mail.ecspc.com0311-67808817

Backup ContactXuefang Xia

xiaxuefang@mail.ecspc.com010-63930702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026