NCT00746317已完成1 期
A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 Administered Weekly in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 9
- 主要终点
- Determine the safety and tolerability of escalating doses of GC33
研究概览
简要总结
This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.
详细描述
This is a Phase I open-label dose escalation study of GC33 in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary assessment of anti-tumor activity. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form
- •Male or female ≥ 18 years old.
- •Life expectancy ≥ 3 months.
- •ECOG Performance Status of 0-
- •Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype).
- •Not a candidate for curative treatments.
- •Child-Pugh A or B.
- •Hematological, Biochemical and Organ Function:
- •AST (SGOT): ≤ 5.0 × ULN
- •ALT (SGPT): ≤ 5.0 × ULN
- •Total Bilirubin: ≤ 3.0 × ULN
- •Platelets: ≥ 50,000/μL
- •Absolute Neutrophil Count: ≥ 1,500/μL
- •Serum creatinine: ≤ 2.0 × ULN
- •PT-INR: ≤ 2.0,
- •Ability to provide a tumor tissue sample either by:
- •a sample obtained within 3 months prior to informed consent for HCC diagnosis. Resection samples are not acceptable.
- •undergo a biopsy to confirm HCC diagnosis
- •At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria.
- •(Extension Phase)
- •Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form.
- •Male or female ≥ 18 years old.
- •Life expectancy ≥ 3 months.
- •ECOG Performance Status of 0-
- •Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype).
- •Not a candidate for curative treatments.
- •Child-Pugh A.
- •Hematological, Biochemical and Organ Function:
- •AST (SGOT): ≤ 5.0 × ULN
- •ALT (SGPT): ≤ 5.0 × ULN
- •Total Bilirubin: ≤ 3.0 × ULN
- •Platelets: ≥ 50,000/μL
- •Absolute Neutrophil Count: ≥ 1,500/μL
- •Serum creatinine: ≤ 2.0 × ULN
- •PT-INR: ≤ 2.0
- •IHC confirmed GPC3-positive HCC tumor tissue. Tumor tissue sample may be provided by:
- •A formalin fixed paraffin embedded block sample within 12 months prior to informed consent for HCC diagnosis;
- •Unstained slides obtained within 3 months prior to informed consent for HCC diagnosis;
- •Undergo biopsy to confirm GPC3-positive HCC.
- •Resection samples are not acceptable.
- •At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria.
排除标准
- •Child-Pugh C.
- •Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
- •Patients known to be positive for Human immunodeficiency virus infection.
- •Active infectious diseases requiring treatment except for hepatitis B and C.
- •Other malignancies within the last 5 years.
- •History of transplantation (organ, bone marrow transplantation,peripheral blood stem cell transplantation, etc.).
- •Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug.
- •Patients with brain metastases, other central nervous system or other psychiatric disease.
- •Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day
- •Patients who received the following treatments within 2 weeks prior to Day1:
- •Anticoagulant or thrombolytic agents for therapeutic purposes.
- •Systemic anti-viral therapy for hepatitis C/cirrhosis.
- •Blood transfusion
- •History of hypersensitivity to similar agents.
- •Patient is unable to comply with the requirements of the protocol and/or follow-up procedures.
- •(Extension Phase)
- •Child-Pugh B or C.
- •Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
- •Patients known to be positive for Human immunodeficiency virus infection.
- •Active infectious diseases requiring treatment except for hepatitis B and C.
- •Other malignancies within the last 5 years.
- •History of transplantation (organ, bone marrow transplantation, Peripheral blood stem cell transplantation, etc.).
- •Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug.
- •Patients with brain metastases, other central nervous system or other psychiatric disease.
- •Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day
- •Patients who received the following treatments within 2 weeks prior to Day 1:
- •Anticoagulations or thrombolytic agents for therapeutic purposes.
- •Systemic anti-viral therapy for hepatitis C/cirrhosis.
- •Blood transfusion
- •History of hypersensitivity to similar agents.
- •Patient is unable to comply with the requirements of the protocol and/or follow-up procedures.
- •IHC confirmed GPC3-negative HCC tumor tissue.
研究组 & 干预措施
1
Experimental
干预措施: GC33 (Drug)
结局指标
主要结局
Determine the safety and tolerability of escalating doses of GC33
时间窗: Continuously
次要结局
- Characterize the pharmacokinetics of GC33(Continuously)
- Perform a preliminary assessment of anti-tumor activity of GC33(Continuously)
研究者
研究点 (9)
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