Hepatocellular CarcinomaPhase 1NCT06088459
NWRD06 DNA Plasmid for HCC After Radical Resection
A Phase 1 study testing 1mg NWRD06 administered by electroporation, 4mg NWRD06 administered by electroporation and 8mg NWRD06 administered by electroporation in people with Hepatocellular Carcinoma, run by Newish Technology (Beijing) Co., Ltd. at 1 site in China.
Trial summary
This is a dose escalation Phase 1 clinical study to evaluate the safety and immunogenicity of Glypican3 (GPC3)-targeted DNA plasmid vaccine (NWRD06) in patients with GPC3-positive primary hepatocellular carcinoma after radical resection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- 1mg NWRD06 administered by electroporation, 4mg NWRD06 administered by electroporation and 8mg NWRD06 administered by electroporation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Nov 2023to Jun 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients had to meet all of the following inclusion criteria:
- 18≤ age ≤60, regardless of gender;
- Diagnosis of primary hepatocellular carcinoma (HCC) by pathohistological examination;
- Immunohistochemical staining that was positive for GPC3;
- Barcelona clinic liver cancer (BCLC) stage A/B or Chinese Hepatocellular carcinoma Stage (CNLC) Ib-IIIa;
- Underwent radical resection of liver cancer (surgery, ablation) followed by hepatic artery interventional therapy before the first NWRD06 administration; The interval between radical resection and the first NWRD06 administration was less than 12 weeks, and the interval between hepatic artery interventional therapy and the first NWRD06 administration was more than 7 days;
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- No residual intrahepatic tumor was found by imaging examination within 4 weeks before the first NWRD06 administration; No lymph node metastasis, no extrahepatic metastasis;
- Patients undergoing radical resection of liver cancer should meet the intraoperative criteria of radical resection of liver cancer:1)There was no invasion of adjacent organs, hilar lymph nodes or distant metastasis during the operation; 2) Negative cutting margin;
- No Vp4 macrovascular invasion, hepatic vein or inferior vena cava macrovascular invasion of any grade after radical resection; Notes: Patients with VP1, VP2 and VP3 macrovascular invasion diagnosed via histopathologic examination or imaging test meet the inclusion criteria.
- Within 1 week before the first NWRD06 administration, ECOG performance status score was 0-1;
- Child-Pugh score A/B (≤7) within 1 week before the first NWRD06 administration;
- Major organ functions were normal within 1 week before the first NWRD06 administration: 1) Blood routine: Hemoglobin (Hb) ≥90 g/L; Platelet count (PLT) ≥75×109/L; 2) The liver: Total bilirubin (TB) ≤3× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; Plasma albumin ≥30g/L; 3)Kidney: Serum creatinine (Scr) ≤1.5×ULN, or creatinine clearance ≥40 mL/min (serum creatinine \> 1.5 x ULN);
- The expected survival time is more than 6 months;
- Patients with non-viral primary HCC meet the inclusion criteria. For patients with Hepatitis B virus-related primary HCC(HBV-HCC) or Hepatitis C virus-related primary HCC(HCV-HCC), antiviral therapies should be carried out simultaneously;
- Within 1 week before the first NWRD06 administration, women of childbearing age must have a negative serum pregnancy test and consent to use effective contraception during the use of the study drug and within 6 months after the last administration of the study drug. For men, they should be surgically sterilized or agree to use effective contraception during study drug use and for 6 months after the last administration of study drug.
- Have fully understood the study and voluntarily signed the ICF, have good communication with the investigator, and are able to complete all treatments, examinations, and visits stipulated in the study protocol.
Who cannot join
- Patients with any of the following were excluded from the study:
- HCC recurred or metastasis before the first NWRD06 administration;
- Before the first NWRD06 administration, the investigator judged that the patient had not fully recovered from the toxicity and/or complications of radical resection;
- Accompanied by hepatic encephalopathy;
- Regular renal dialysis is required;
- with uncontrolled pleural effusion, pericardial effusion, or moderate or more ascites (refers to ascites that cannot be easily controlled by diuretic treatment);
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- A history of gastrointestinal bleeding, current active bleeding, or bleeding tendency within 28 days before screening;
- Had received systemic antitumor therapy (including chemotherapy, molecular targeted therapy, biological immunotherapy) for liver cancer within 28 days before screening;
- Participated in another clinical trial or was under observation in another clinical trial within 28 days prior to screening;
- Continuous (more than 1 week) glucocorticoid therapy (dose equivalent to prednisone \> 10 mg/ day), except hormone replacement therapy and intratracheal administration;
- A history of immune deficiency or autoimmune diseases (e.g., rheumatoid joint disease, systemic lupus erythematosus, multiple sclerosis, etc.);
- A history of allogeneic stem cell/tissue/solid organ transplantation (including bone marrow transplantation);
- With uncontrolled severe infection (> grade 2 NCI-CTCAE adverse events, version 5.0);
- Patients with a history of human immunodeficiency virus (HIV) infection or carriers of syphilis;
- Patients with serious other organ dysfunction or cardiopulmonary diseases;
- Epilepsy that requires treatment with medication (e.g. steroids or antiepileptic drugs);
- Had or currently has other malignancies (with the exception of adequately treated and completely cured ductal carcinoma in situ of the breast, carcinoma in situ of the cervix, basal cell carcinoma of the skin, superficial bladder tumor, or any malignancy that was cured more than 5 years before study entry);
- A known history of albumin allergy, or severe allergy, or allergic disease, or allergic constitution, or severe iodine contrast allergy, meeting any of these criteria;
- Severe mental illness;
- A history of drug or alcohol abuse;
- Pregnant or lactating women, or women of childbearing age with positive blood pregnancy tests;
- Patients deemed by the investigator to be ineligible for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Zhen Huang, M.D., 86-010-87787100, huangzhen@cicams.ac.cn
Hong Zhao, M.D.
About this study
Official title: Phase I Safety and Immunogenicity Study of NWRD06 in Hepatocellular Carcinoma Patients After Radical Resection
This is a dose escalation Phase 1 clinical study to evaluate the safety and immunogenicity of Glypican3 (GPC3)-targeted DNA plasmid vaccine (NWRD06) in patients with GPC3-positive primary hepatocellular carcinoma after radical resection.
Read the detailed description
This study is divided into three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD06 by electroporation in entire study period. The Maximum tolerated dose of NWRD06 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration.
Immunologic reactogenicity in blood samples was assessed at week 0, week 2, week 4, week 6, week 8, week 10, week 12.
Peripheral blood samples were then collected every 3 months for immunogenicity assessment until disease progression or specific immune response became undetectable or the study was withdrawn for various reasons or ended (whichever occurred first).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- 1mg NWRD06 administered by electroporation, 4mg NWRD06 administered by electroporation, 8mg NWRD06 administered by electroporation
- Keywords
- Hepatocellular Carcinoma, Naked DNA Vaccine, GPC3
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1mg NWRD06 administered by electroporationBiological
DNA plasmid delivered via IM injection + electroporation using TERESA device
4mg NWRD06 administered by electroporationBiological
DNA plasmid delivered via IM injection + electroporation using TERESA device
8mg NWRD06 administered by electroporationBiological
DNA plasmid delivered via IM injection + electroporation using TERESA device
| Study group | Role | What they receive |
|---|---|---|
| NWRD06 by electroporation | Experimental | Patients will be assigned to three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD06 by electroporation in entire study period. The Maximum Tolerated Dose of NWRD06 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18. Receives: Biological: 1mg NWRD06 administered by electroporation; Biological: 4mg NWRD06 administered by electroporation; Biological: 8mg NWRD06 administered by electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs that is definitely, probably, or possibly related to the test drug occurring within 28 days of the last dosing will be classified as DLT during dosing climb.
Measured: From first administration of NWRD06 to 28 days after the last administration
All adverse events (AE)
All adverse events (AE) will be determined based on the rate and severity grade of events, including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events)
Measured: 12 weeks
Secondary outcomes (1)
Immunogenicity
GPC3 specific immune response in peripheral blood
Measured: At week 0, week 2, week 4, week 6, week 8, week 10, week 12 and then collected every 12 weeks until disease progression or specific immune response became undetectable or the study was withdrawn for various reasons or ended (whichever occurred first).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- This study is divided into three dose groups climbed from low-dose group to high-dose group in turn according to the 3+3 dose escalation principle. Three dose groups were preset in this study: dose group 1 and low-dose group \[a single dose of 1mg was administered three times at week 0, 4 and 8, respectively, with cumulative administration of 3mg\]; Dose group 2, middle-dose group \[single dose of 4mg, administered 3 times at week 0, 4, 8, respectively, cumulative administration of 12mg\]; Dose group 3, high-dose group \[a single dose of 8mg, administered at week 0, 4 and 8, a total of 3 times, cumulative administration of 24mg\]. After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newish Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhao Hong, Ph.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088459
- Sponsor's protocol ID
- NEWISH-GPC3-101
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Immunogenicity Study of NWRD06 in Hepatocellular Carcinoma Patients After Radical Resection
- ClinicalTrials.gov ID
- NCT06088459
- Acronym / sponsor ID
- NEWISH-GPC3-101
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Naked DNA Vaccine, GPC3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Newish Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Oct 2023 (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 Phase 1 clinical study to evaluate the safety and immunogenicity of Glypican3 (GPC3)-targeted DNA plasmid vaccine (NWRD06) in patients with GPC3-positive primary hepatocellular carcinoma after radical resection.
Detailed description
This study is divided into three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD06 by electroporation in entire study period. The Maximum tolerated dose of NWRD06 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration.
Immunologic reactogenicity in blood samples was assessed at week 0, week 2, week 4, week 6, week 8, week 10, week 12.
Peripheral blood samples were then collected every 3 months for immunogenicity assessment until disease progression or specific immune response became undetectable or the study was withdrawn for various reasons or ended (whichever occurred first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is divided into three dose groups climbed from low-dose group to high-dose group in turn according to the 3+3 dose escalation principle. Three dose groups were preset in this study: dose group 1 and low-dose group [a single dose of 1mg was administered three times at week 0, 4 and 8, respectively, with cumulative administration of 3mg]; Dose group 2, middle-dose group [single dose of 4mg, administered 3 times at week 0, 4, 8, respectively, cumulative administration of 12mg]; Dose group 3, high-dose group [a single dose of 8mg, administered at week 0, 4 and 8, a total of 3 times, cumulative administration of 24mg]. After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration.
| Arm | Type | Receives |
|---|---|---|
| NWRD06 by electroporation | Experimental | Biological: 1mg NWRD06 administered by electroporation, Biological: 4mg NWRD06 administered by electroporation, Biological: 8mg NWRD06 administered by electroporationPatients will be assigned to three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD06 by electroporation in entire study period. The Maximum Tolerated Dose of NWRD06 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 18≤ age ≤60, regardless of gender;
- Diagnosis of primary hepatocellular carcinoma (HCC) by pathohistological examination;
- Immunohistochemical staining that was positive for GPC3;
- Barcelona clinic liver cancer (BCLC) stage A/B or Chinese Hepatocellular carcinoma Stage (CNLC) Ib-IIIa;
- Underwent radical resection of liver cancer (surgery, ablation) followed by hepatic artery interventional therapy before the first NWRD06 administration; The interval between radical resection and the first NWRD06 administration was less than 12 weeks, and the interval between hepatic artery interventional therapy and the first NWRD06 administration was more than 7 days;
Key exclusion criteria (22 listed)
- HCC recurred or metastasis before the first NWRD06 administration;
- Before the first NWRD06 administration, the investigator judged that the patient had not fully recovered from the toxicity and/or complications of radical resection;
- Accompanied by hepatic encephalopathy;
- Regular renal dialysis is required;
- with uncontrolled pleural effusion, pericardial effusion, or moderate or more ascites (refers to ascites that cannot be easily controlled by diuretic treatment);
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 |
|---|---|---|
| 1mg NWRD06 administered by electroporationDNA plasmid delivered via IM injection + electroporation using TERESA device | Biological | NWRD06 by electroporation |
| 4mg NWRD06 administered by electroporationDNA plasmid delivered via IM injection + electroporation using TERESA device | Biological | NWRD06 by electroporation |
| 8mg NWRD06 administered by electroporationDNA plasmid delivered via IM injection + electroporation using TERESA device | Biological | NWRD06 by electroporation |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: From first administration of NWRD06 to 28 days after the last administration
It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs that is definitely, probably, or possibly related to the test drug occurring within 28 days of the last dosing will be classified as DLT during dosing climb.
All adverse events (AE)
Time frame: 12 weeks
All adverse events (AE) will be determined based on the rate and severity grade of events, including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events)
1 secondary outcome
Immunogenicity
Time frame: At week 0, week 2, week 4, week 6, week 8, week 10, week 12 and then collected every 12 weeks until disease progression or specific immune response became undetectable or the study was withdrawn for various reasons or ended (whichever occurred first).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Zhao Hong, Ph.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1mg NWRD06 administered by electroporation, 4mg NWRD06 administered by electroporation and 8mg NWRD06 administered by electroporation in people with Hepatocellular Carcinoma, run by Newish Technology (Beijing) Co., Ltd. at 1 site in China.
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 16 inclusion and 22 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Defang Liu, Ph.D. ((86)010-87661655, ldf@newishes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: From first administration of NWRD06 to 28 days after the last administration). The study lists 2 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 18 Oct 2023.