An Open-label, Multicenter, Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Non-resectable, Non-transplantable, Non-radiofrequency Ablation (RFA) Treatable Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) observed during the trial
研究概览
简要总结
Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. TBI 302 is being developed for the treatment of inoperable HCC by intravenous infusion. The objective is to determine the safety and tolerability of TBI 3002.
详细描述
This is an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and MTD of TBI 302 in patients with non-resectable, non-transplantable HCC. Tumor response will be assessed at Week 9 (5 weeks following cessation of treatment) according to RECIST (ver 1.1) and AASLD criteria.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients histologically or cytologically confirmed, unresectable, or metastatic HCC
- •Child-Pugh Category A or B (score 6-7); stable, well-compensated, mild cirrhosis with minimal or no ascites
- •Male or female patients 18 years of age or older
- •Patients must be willing and able to read, understand and sign a written informed consent form
- •Male, or female of childbearing potential, must agree to use double barrier contraception, oral contraceptives or other ways to avoid pregnancy during the study and for 90 days after the last day of treatment
- •Life expectancy of greater than 3 months
- •Plasma haptoglobin ≥ LLN (lower limit of normal)
排除标准
- •Patients confirmed with hemolysis confirmed by serum lactate dehydrogenase, serum haptoglobin or indirect bilirubin levels
- •Patients who have received a blood transfusion within 4 weeks of enrolment
- •Patients with infiltrating diffuse hepatocellular carcinoma, Type 1 or 2 diabetes mellitus, Hepatitis B or Hepatitis C infection
- •Systemic chemotherapy-naive patients
- •Patients with significant cardiovascular impairment, including history of congestive heart failure, unstable angina, myocardial infarction, or serious cardiac arrhythmia within the last 6 months
- •Patient with a history of tumor rupture
- •Patients with serious non-healing wound , ulcer or bone fracture
- •Known positive human immunodeficiency virus (HIV) test
研究组 & 干预措施
TBI 302 Safety, Tolerability
5 Cohorts, Dose escalation TBI 302 will be formulated in 0.9% saline. TBI 302 in a syringe will be administered over approximately 1 hour under constant observation once per week for 4 weeks (on Days 1, 8, 15 and 22).
干预措施: TBI 302 (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) observed during the trial
时间窗: through study completion, up to one year
The number of TEAEs observed during the trial
次要结局
- Determination of Maximum Tolerated Dose(through study completion, up to one year)