A Multicenter, 3-Arm, Open-Label, Phase Ⅱa Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Adverse events
研究概览
简要总结
Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial
Study objective:
- Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.
- Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent glioblastoma.
- Exploratory
- To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent glioblastoma
- To evaluate pharmacodynamic (PD) parameters by clinical biomarker test
Study Methodology
Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to determine the patient's safety with a decision on enrollment into the next arm or change in dosing frequency of study drug in the above case.
A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient. Patients will be treated for up to 1 year, unless a cause for termination occurs, such as progression of disease (PD) or the withdrawal of consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female patients ≥19 years old
- •Diagnosed with primary glioblastoma by histopathological examination and confirmed recurrent glioblastoma by magnetic resonance imaging (MRI) scans after concomitant temozolomide chemotherapy with radiotherapy (CCRT). One previous recurrence/progression of glioblastoma with reintroduction/altered schedule of temozolomide is allowable.
- •At least one confirmed measurable lesion or non measurable lesion by response assessment in neuro-oncology (RANO) criteria
- •Karnofsky Performance Status (KPS) ≥ 80
- •A person who satisfies the following criteria in hematologic, renal, and hepatic function tests
- •At least 12 weeks of expected survival time
- •Signed informed consent
排除标准
- •Diagnosed with other malignant tumor within 2years
- •Uncontrolled HT or seizure, class III or IV heart failure, oxygen dependent disease, active psychiatric disorder
- •Not recovered grade 2 AE due to previous CCRT
- •Major surgery or other investigational drug treatment within 4 weeks
- •Pregnant/lactating female and female/male potential childbearing without contraception
- •Severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug
- •Expectation of poor compliance
- •Previous therapy with VEGF targeted agent
研究组 & 干预措施
Cohort 1
Patients will be treated with 8mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
干预措施: TTAC-0001 (Drug)
Cohort 2
Patients will be treated with 12mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle.
干预措施: TTAC-0001 (Drug)
Cohort 3
Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle.
干预措施: TTAC-0001 (Drug)
结局指标
主要结局
Adverse events
时间窗: up to 1 year
次要结局
- PFS at 6-month time point(6 months)
- Overall survival(OS)(up to 1 year)
- Objective response rate (ORR)(up to 1 year)
- Disease control rate(DCR)(up to 1 year)