Advanced Hepatocellular CarcinomaPhase 1NCT04331743
A Study to Evaluate the Safety and Efficacy of PLM60 in Advanced HCC
A Phase 1 study testing Liposome-entrapped Mitoxantrone Hydrochloride Injection in people with Advanced Hepatocellular Carcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Liposome-entrapped Mitoxantrone Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2021to 1 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 9Show fewer
- History of liver transplantation, severe cirrhosis, hepatic encephalopathy;
- Inadequate cardiac function;
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- Liposome-entrapped Mitoxantrone Hydrochloride Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome-entrapped Mitoxantrone Hydrochloride InjectionDrug
Also called PLM60
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| PLM60 | Experimental | 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). Receives: Drug: Liposome-entrapped Mitoxantrone Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limited toxicity (DLT)
To identify the dose-limited toxicity (DLT).
Measured: 1year
Maximum tolerated dose (MTD)
To identify the maximum tolerated dose (MTD).
Measured: 1 year
Recommended Phase II Dose (RP2D)
To identify the Recommended Phase II Dose (RP2D)
Measured: 1 year
Secondary outcomes (7)
Area under the plasma concentration versus time curve (AUC)
To preliminarily evaluate the AUC in patients with advanced HCC.
Measured: 2 years
Peak Plasma Concentration (Cmax)
To preliminarily evaluate Cmax in patients with advanced HCC.
Measured: 2 years
Time of peak plasma concentration (Tmax)
To preliminarily evaluate Tmax in patients with advanced HCC.
Measured: 2 years
Median overall survival (OS)
To preliminarily evaluate ORR in patients with advanced HCC.
Measured: 2 years
Median progression free survival (PFS)
To preliminarily evaluate PFS in patients with advanced HCC.
Measured: 2 years
Overall response rate (ORR)
To preliminarily evaluate ORR in patients with advanced HCC.
Measured: 2 years
Duration of Response (DoR)
To preliminarily evaluate DoR in patients with advanced HCC.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start5 Jun 2021 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331743
- Sponsor's protocol ID
- PLM60-HCC-201901/PRO
- Status last verified
- Jun 2021
- First submitted
- 12 Mar 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04331743
- Acronym / sponsor ID
- PLM60-HCC-201901/PRO
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2021 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLM60 | Experimental | Drug: Liposome-entrapped Mitoxantrone Hydrochloride InjectionThree 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposome-entrapped Mitoxantrone Hydrochloride InjectionAlso: PLM60Intravenous infusion | Drug | PLM60 |
Primary outcome
Dose-limited toxicity (DLT)
Time frame: 1year
To identify the dose-limited toxicity (DLT).
Maximum tolerated dose (MTD)
Time frame: 1 year
To identify the maximum tolerated dose (MTD).
Recommended Phase II Dose (RP2D)
Time frame: 1 year
To identify the Recommended Phase II Dose (RP2D)
7 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: 2 years
Peak Plasma Concentration (Cmax)
Time frame: 2 years
Time of peak plasma concentration (Tmax)
Time frame: 2 years
Median overall survival (OS)
Time frame: 2 years
Median progression free survival (PFS)
Time frame: 2 years
Overall response rate (ORR)
Time frame: 2 years
Duration of Response (DoR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 2
A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Not yet recruitingPhase 2
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Cancer, Liver Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposome-entrapped Mitoxantrone Hydrochloride Injection in people with Advanced Hepatocellular Carcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Lou (0311-67808817, loukun@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limited toxicity (DLT) (time frame: 1year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.