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This is an open label, single-site, investigator-initiated trial designed to evaluate the safety, tolerability and preliminary efficacy of ABOR2014(IPM511) injection in relapsed/ refactory HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPM511 monotherapy | Experimental | 3+3 dose excalation. Paticipants will receive two cycle (QWX4 per cycle) IPM511 injection,I.M injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen vaccine, I.M injection | Drug | Patients will receive a fixed applicable dose of ABOR2014(IPM511) administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AE) | AE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). | up to 12 months |
| Clinically significant abnormal changes in vital signs | up to 12 months | |
| Clinically significant abnormal changes in laboratory tests | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] of IPM511 | up to 12 months | |
| Time of Maximum Plasma Concentration [Tmax] of IPM511 | up to 12 months | |
| Half-time of Plasma Concentration [T1/2] of IPM511 |
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Inclusion Criteria:
Subjects who understand and voluntarily sign the informed consent form;
Male or female subjects ≥ 18 years old;
Patients with pathological or cytological evidence of locally advanced or hepatocellular carcinoma, who have failed or are intolerant of previous standard treatments;
At least one measurable lesion judged according to the RECIST version 1.1 standard.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (inclusive);
Life expectancy ≥ 12 weeks;
HLA typing: A-02;
Laboratory tests at screening shall meet the following requirements:
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:
9. For patients of childbearing potential (male or female), effective contraceptive measures shall be taken during the study treatment and within 3 months after the last dose. For women of childbearing potential, a negative serum/urine HCG test result within 7 days prior to study enrollment shall be provided.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao haitao, Dr | Contact | 010-69156114 | zhaoht@pumch.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| up to 12 months |
| Antigen-specific T-cell responses in peripheral blood | Detected by Tetramer or TCRseq or Enzyme-linked Immunospot Assay(ELISPOT) | up to 12 months |
| Change of Circulating tumor DNA (ctDNA) status (every 6 weeks) | up to 12 months |
| Objective Response Rate, ORR | ORR is Defined as the number of patients with a complete response (CR) or partial response(PR) . | up to 12 months |
| Duration of Response, DoR | DoR is defined as time from first tumor response(partial or complete) until either radiogical disease progress, clinical/ symptomatic disease progression or death (whichever is sooner). | up to 12 months |
| Progress Free Survival, PFS | PFS is defined as time between the date of first dose of IPM511 and the date either radiogical disease progress, clinical/ symptomatic disease progression or death (whichever is sooner). | up to 12 months |
| Overall Survival, OS | OS is defined as time between the date of first dose of IPM511 and the date of death due to any cause. | up to 12 months |