Hepatocellular CarcinomaPhase 1NCT05536427
Safety and Efficacy of IPM001 in Patients With Advanced Hepatocellular Carcinoma
A Phase 1 study testing IPM001 in people with Hepatocellular Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
In this study, safety and effects of IPM001 injection on human hepatocellular carcinoma are going to be investigated, IPM001 is a multiple tumor-associated antigen (TAA) and neoantigen/tumor-specific antigen (TSA) sensitized autoimmune cell injection Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- IPM001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Oct 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who understand and voluntarily sign the informed consent forms;
- Subjects aged 18-75 years old (inclusive), male or female;
- Subjects with progressive hepatocellular carcinoma who failed second-line therapy;
- Subjects with an expected survival ≥ 6 months;
- Subjects with a Child-Pugh score ≤ 7;
- Subjects with an HLA A-02 genotype;
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- Subjects with a TBS score < 8;
- Subjects with an ECOG score of 0-2 (inclusive);
- Male and female subjects of childbearing potential must agree to use highly effective contraceptive methods during the entire study and for at least 3 months after receiving the last treatment, and women of childbearing age must have a negative pregnancy test;
- Weight: Male > 50 kg, female > 45 kg;
- Subjects with liver tumor lesions that can be used for tumor tissue biopsy. If feasible, the subjects must agree to provide tumor tissue specimens at baseline;
- Subjects with no major organ dysfunctions (by laboratory test): ① white blood cell count ≥ 3.0 × 109/L; ② neutrophil count ≥ 1.5 × 109/L; ③ hemoglobin ≥ 90 g/L; ④ platelet count ≥ 30 × 109/L; ⑤ total bilirubin ≤ 2 × ULN; ⑥ Serum AST (GOT) and ALT (GPT) ≤ 2.5 × ULN; ⑦ albumin ≥ 3.0 g/dL (30 g/L); ⑧ blood creatinine ≤ 1.5 × ULN; ⑨ generally normal bleeding and coagulation time, with PT prolongation ≤ 4 s; ⑩ no serious cardiopulmonary diseases;
- For subjects with hepatitis B-related primary hepatocellular carcinoma (HBV-HCC) or hepatitis C-related primary hepatocellular carcinoma (HCV-HCC), those who are with the following conditions are eligible to be enrolled:
- HBV-HCC: resolved HBV infection (specified as with positive HBV surface antibody and HBV core antibody, negative HBV surface antigen, and the HBV-DNA below the lower limit of detection); chronic HBV infection (specified as with positive HBV surface antigen or the HBV-DNA above the lower limit of detection, as well as the HBV-DNA less than 106 copies/mL), with concomitant antiviral therapy.
- HCV-HCC: resolved or active HCV infection (specified as with positive HCV antibody or the HCV-RNA above the lower limit of detection, as well as the HCV-RNA less than 103 copies/mL), where concomitant antiviral therapy may be given for active HCV infection.
- Subjects with no obvious genetic diseases;
- Subjects who have not received any live attenuated vaccines within 4 weeks prior to the first administration;
- Subjects who are able to follow the clinical study protocol and follow-up procedures.
Who cannot join
- Subjects with immunodeficiency or a history of autoimmune disorders (e.g., rheumatoid arthropathy, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes mellitus, etc.);
- Subjects with severe concurrent medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, serious infection and infectious disease, active peptic ulcer, presence of active hemorrhage, and severe organ failure;
- Subjects with myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, Grade III or IV cardiac failure defined by the New York Heart Association (NYHA), epileptic seizure, and mechanical or paralytic ileus within 6 months prior to the first administration of the investigational drug;
- Subjects who have received chemotherapy and hormonal therapy within 28 days prior to signing the informed consent forms, or are currently taking other investigational drugs;
- Subjects with lymphoma, leukemia, myelodysplastic syndrome (MDS), or myelosuppression;
- Subjects with allergy or a history of hypersensitivity to human blood albumin, or a history of allergy or hypersensitivity to any investigational drug or its excipients;
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- Subjects with chronic diseases requiring immunotherapy or hormonal therapy; and subjects currently receiving corticosteroids for other diseases (except those using topical or inhaled steroids);
- Pregnant or lactating women;
- Subjects with mental or neurological disorders that are not easily controlled;
- Subjects infected with human immunodeficiency virus (commonly known as AIDS) or treponema pallidum (commonly known as syphilis);
- Subjects with a history of other malignant tumors within the last 5 years;
- Subjects with prior allogeneic stem cell transplantation or solid organ transplant;
- Subjects with a history of drug or alcohol abuse;
- Subjects with any irAE of ≥ Grade 3 following prior immunotherapy;
- Subjects who, in the judgment of the investigator, are not suitable to participate in this clinical study (e.g., with poor compliance).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100005
Zhu Chengpei, Dr, 13720019126, pumchzcp@126.com
About this study
Official title: An Open-Label, Multi-Center, Multiple-Dose, Dose-Escalation and Dose-Expansion, Investigator-Initiated Phase I Clinical Study to Observe and Evaluate the Tolerability, Safety, Pharmacodynamics, and Preliminary Efficacy of IPM001 Injection in the Treatment of Progressive Hepatocellular Carcinoma
In this study, safety and effects of IPM001 injection on human hepatocellular carcinoma are going to be investigated, IPM001 is a multiple tumor-associated antigen (TAA) and neoantigen/tumor-specific antigen (TSA) sensitized autoimmune cell injection
- Conditions
- Hepatocellular Carcinoma
- Being tested
- IPM001
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPM001Biological
IPM001 will be used against tumor cells
| Study group | Role | What they receive |
|---|---|---|
| IPM001 | Experimental | A neoantigen/ tumor-specific antigen sencitized autoimmune cell injection Receives: Biological: IPM001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety (AE/ irAE/ SAE)
Adverse events, Immue-related adverse，serious adverse event
Measured: 12 months
Tolerance(DLT/ MTD/ OBD)
Dose Limiting Toxicity, Maximum Tolerated Dose, Optimal Biological Dose
Measured: 12 months
Secondary outcomes (2)
Progression-free Survival (PFS)
The time between the NeoAg/aeTSA CTL initiation and the onset of tumor progress or death from any cause
Measured: 12 months
Overall Survival (OS)
From the beginning of NeoAg/aeTSA CTL initiation to the time of death from any cause
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Oct 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (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.
- More trials run by Peking Union Medical College HospitalThe 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Immupeutics Medicine Technology Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536427
- Sponsor's protocol ID
- I-22PJ157
- Status last verified
- Aug 2022
- First submitted
- 7 Sep 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Multiple-Dose, Dose-Escalation and Dose-Expansion, Investigator-Initiated Phase I Clinical Study to Observe and Evaluate the Tolerability, Safety, Pharmacodynamics, and Preliminary Efficacy of IPM001 Injection in the Treatment of Progressive Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05536427
- Acronym / sponsor ID
- I-22PJ157
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Immupeutics Medicine Technology Limited
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 10 Sep 2022 (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.
In this study, safety and effects of IPM001 injection on human hepatocellular carcinoma are going to be investigated, IPM001 is a multiple tumor-associated antigen (TAA) and neoantigen/tumor-specific antigen (TSA) sensitized autoimmune cell injection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPM001 | Experimental | Biological: IPM001A neoantigen/ tumor-specific antigen sencitized autoimmune cell injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects who understand and voluntarily sign the informed consent forms;
- Subjects aged 18-75 years old (inclusive), male or female;
- Subjects with progressive hepatocellular carcinoma who failed second-line therapy;
- Subjects with an expected survival ≥ 6 months;
- Subjects with a Child-Pugh score ≤ 7;
Key exclusion criteria (15 listed)
- Subjects with immunodeficiency or a history of autoimmune disorders (e.g., rheumatoid arthropathy, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes mellitus, etc.);
- Subjects with severe concurrent medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, serious infection and infectious disease, active peptic ulcer, presence of active hemorrhage, and severe organ failure;
- Subjects with myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, Grade III or IV cardiac failure defined by the New York Heart Association (NYHA), epileptic seizure, and mechanical or paralytic ileus within 6 months prior to the first administration of the investigational drug;
- Subjects who have received chemotherapy and hormonal therapy within 28 days prior to signing the informed consent forms, or are currently taking other investigational drugs;
- Subjects with lymphoma, leukemia, myelodysplastic syndrome (MDS), or myelosuppression;
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 |
|---|---|---|
| IPM001IPM001 will be used against tumor cells | Biological | IPM001 |
Primary outcome
safety (AE/ irAE/ SAE)
Time frame: 12 months
Adverse events, Immue-related adverse，serious adverse event
Tolerance(DLT/ MTD/ OBD)
Time frame: 12 months
Dose Limiting Toxicity, Maximum Tolerated Dose, Optimal Biological Dose
2 secondary outcomes
Progression-free Survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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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.
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 IPM001 in people with Hepatocellular Carcinoma, run by Peking Union Medical College Hospital 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 18 inclusion and 15 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 2 Mar 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 Chengpei Zhu, MD (13720019126, puchzcp@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (AE/ irAE/ SAE) (time frame: 12 months). 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 2 Mar 2023.