NCT05652920招募中1 期
A Phase Ib/II, Open-Label, Multi-Center Study to Investigate the Safety, PK, and Efficacy of Ori-C101 in Advanced Hepatocellular Carcinoma (HCC) Patients (BEACON)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 7
- 主要终点
- Maximum tolerated dose of Ori-C101
研究概览
简要总结
This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed pathologic or radiologic diagnosis of HCC ;
- •Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the local laboratory (Tumor samples ≤1 years prior to ICF signature are acceptable), if no archived tumor tissue samples, tumor biopsy is required for GPC3 expression test;
- •Unresectable stage B (intermediate) or C (advanced) HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. If stage B, must have progressed after, or not be eligible for, surgical or locoregional therapy;
- •Received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic disease progression during or following systemic therapy;
- •Child-Pugh A or B7, no history of hepatic encephalopathy;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature;
- •Estimated life expectancy of minimum of 12 weeks;
- •Must have at least 1 target lesion
排除标准
- •Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
- •Prior bone marrow or organ transplantation;
- •Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ;
- •Active hepatitis B infection (If Hepatitis B surface antigen [HBsAg] or Hepatitis B core antibody [HBcAb] positive, then HBV-DNA must be < 20 IU/mL, and HBsAg-positive patients should have been treated with antiviral therapies as per the local guidelines);
- •Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;
- •Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
- •Inadequate bone marrow reserve or organ function;
- •History or current evidence of any condition or disease that could confound the results of the study or, in the opinion of Investigator, is not in the best interest of the patient to participate.
- •Pregnant or Breast-feeding women.
结局指标
主要结局
Maximum tolerated dose of Ori-C101
时间窗: 1 year
The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.
次要结局
- Objective Response Rate(2 years)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
1 期
A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate CancerProstate CancerNCT04087174AstraZeneca27
招募中
1 期
A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid TumorsAdvanced Solid TumorNSCLCNCT05417321Shanghai Huaota Biopharmaceutical Co., Ltd.80
Unknown
1 期
A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/NeoplasmsAcute Myeloid LeukemiaNCT04272957Hutchison Medipharma Limited75
招募中
1 期
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid TumorsAdvanced Solid TumorCervical CancerNCT06223308Shanghai Huaota Biopharmaceutical Co., Ltd.54
Unknown
1 期
A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular DegenerationNeovascular Age-Related Macular DegenerationNCT03021785Jiangsu T-Mab Biopharma Co.,Ltd36