NCT05981066招募中不适用
An Open, Single-center, Multiple-dose, Dose-increasing and Dose-expanding Clinical Study to Observe and Evaluate the Safety, Tolerance, Immunokinetics and Preliminary Effectiveness of ABOR2014 Injection (IPM511) in the Treatment of Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Clinically significant abnormal changes in vital signs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- •Platelet count (PLT) ≥ 90 × 10^9/L;
- •Hemoglobin (Hb) ≥ 90 g/L;
- •Total bilirubin (TBIL) ≤ 3 × ULN;
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN;
- •Blood creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (calculated based on Cockcroft-Gault formula) ≥ 45 mL/min;
- •International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;
- •QTc interval (calculated based on Fridericia's formula) ≤ 450 ms for males and ≤ 470 ms for females;
- •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 with concomitant antiviral therapy;
- •HCV-HCC: resolved or active HCV infection , where concomitant antiviral therapy may be given for active HCV infection;
- •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.
排除标准
- •Known allergy to any of the components of the investigational product;
- •History of topical treatment with mRNA products or treatment with mRNA vaccines;
- •Patients with a history of major operations within 4 weeks before the first dose, have a plan of major operations during the study (at the investigator's discretion);
- •History of anti-tumor therapies within 4 weeks before the first dose;
- •History of receiving immunosuppressive drugs within 4 weeks before the first dose, except for corticosteroid nasal sprays, inhalants, and systemic prednisone at a dose of ≤ 10 mg/day or similar drugs at equivalent doses;
- •History of organ transplant, bone marrow transplant, or hematopoietic stem cell transplant;
- •History of hemorrhagic diseases such as anaphylactoid purpura, Haemophilia and aplastic anemia;
- •History of live attenuated vaccines within 30 days before the first dose;
- •Central nervous system (CNS) metastases that are symptomatic, untreated, or require continuous treatment;
- •Toxicological events (except alopecia and pigmentation) have not recovered to baseline or NCI-CTCAE v5.0 grade 0-1 after prior anti-tumor therapies;
- •History of autoimmune disorders;
- •History of immediate hypersensitivity, eczema that cannot be controlled by topical corticosteroids, or asthma;
- •Uncontrollable concomitant diseases;
- •Active infections currently requiring systemic anti-infective therapy; active pulmonary tuberculosis;
- •Known history of human immunodeficiency virus (HIV) positive or treponema pallidum positive;
- •Patients with other conditions that are not suitable for participation in the study at the discretion of the investigator.
研究组 & 干预措施
IPM511 monotherapy
Experimental
3+3 dose excalation. Paticipants will receive two cycle (QWX4 per cycle) IPM511 injection，I.M injection
干预措施: Neoantigen vaccine, I.M injection (Drug)
结局指标
主要结局
Clinically significant abnormal changes in vital signs
时间窗: up to 12 months
Incidence and severity of adverse events (AE)
时间窗: up to 12 months
AE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Clinically significant abnormal changes in laboratory tests
时间窗: up to 12 months
次要结局
- Half-time of Plasma Concentration [T1/2] of IPM511(up to 12 months)
- Antigen-specific T-cell responses in peripheral blood(up to 12 months)
- Change of Circulating tumor DNA (ctDNA) status (every 6 weeks)(up to 12 months)
- Objective Response Rate, ORR(up to 12 months)
- Time of Maximum Plasma Concentration [Tmax] of IPM511(up to 12 months)
- Duration of Response, DoR(up to 12 months)
- Maximum Plasma Concentration [Cmax] of IPM511(up to 12 months)
- Progress Free Survival, PFS(up to 12 months)
- Overall Survival, OS(up to 12 months)
研究者
研究点 (1)
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