NCT03856099终止2 期
A Multicenter, Open-Label, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy
PharmAbcine3 个研究点 分布在 2 个国家目标入组 19 人开始时间: 2019年11月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Adverse Events
研究概览
简要总结
This is a phase II, open-Label clinical trial to evaluate the safety and efficacy of TTAC-0001 in patients with recurrent glioblastoma who was progressed on bevacizumab including therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent prior to any study specific procedures, sampling or analyses.
- •Aged at least 18 years old
- •Patients must have a histologically proven diagnosis of glioblastoma/gliosarcoma
- •Patients must have previous treatment including bevacizumab
- •Patients must have a radiological diagnosis of recurrent/relapsed or progressive glioblastoma/gliosarcoma after bevacizumab including therapy according to response assessment in neuro-oncology (RANO) criteria
- •At least one confirmed measurable lesion or non measurable lesion as determined by RANO criteria
- •Patients must undergo IDH1 mutational testing on a tumor specimen before entering the study. Immunohistochemistry (IHC) is sufficient for enrollment, although DNA sequencing may also be performed as per local institutional guidelines. Patients are eligible regardless of their tumor status.
- •Karnofsky Performance Status (KPS) ≥ 70
- •A person who satisfies the following criteria in hematologic, renal, and hepatic function tests (1) Hematologic tests - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelets ≥ 75 x 109/L
- •Hemoglobin ≥ 9.0 g/dL (2) Blood coagulation tests
- •Prothrombin time (PT) ≤ 1.5 x Upper limit of normal (ULN)
- •Activated partial thromboplastin Time (aPTT) ≤ 1.5 x ULN (3) Hepatic function tests
- •Total bilirubin ≤ 1.5 x ULN
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x ULN (4) Renal function test
- •Creatinine clearance (CrCl) ≥ 30 mL/minute calculated by Cockcroft-Gault formula
- •Life expectancy of at least 12 weeks
- •Females of child bearing potential must have a negative pregnancy test during screening and must not be breastfeeding or intending to become pregnant during the study.
- •Male patients with female partners of child-bearing potential must be willing to use two forms of acceptable contraception, including one barrier method, during their participation in this study and for 16 weeks following the last dose of the study. Refer to section 10.5.1 Restrictions, permitted methods of contraception and definitions.
排除标准
- •Diagnosed with malignant tumors, except basal cell carcinoma, cutaneous squamous cell carcinoma, and noninvasive uterine cervical cancer treated within 2 years prior to receiving the first dose of treatment.
- •The following concomitant diseases:
- •(1) Uncontrolled hypertension (systolic blood pressure [SBP] > 150 or diastolic blood pressure [DBP] > 90 mmHg) (2) Uncontrolled seizures (3) Class III or IV heart failure according to New York Heart Association (NYHA) classification (4) Oxygen-dependent chronic disease (5) Active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder etc.). Treated depression with ongoing antidepressant medication is not an exclusion.
- •Not recovered from AEs < National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 2 caused by CCRT 4) Treatment with bevacizumab including therapy 2 weeks prior to receiving the first dose of treatment.
- •Undergone major surgery requiring general anesthesia or a respiratory assistance device within 4 weeks prior to the baseline visit (within 2 weeks for video-assisted thoracoscopic surgery [VATS] or open-and-closed [ONC] surgery) 6) Treated with other investigational products within 4 weeks prior to the patient receiving the first dose of treatment.
- •A known history of severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug 8) Unable to participate in the trial according to the investigator's decision. 9) Patient not eligible for sequential MRI evaluations are not eligible for this study 10) Previous therapy with VEGF-targeted agents except bevacizumab. 11) Known active hepatitis B or hepatitis C infection 12) Has received a live vaccine within 30 days prior to enrollment. Seasonal flu vaccines that do not contain live virus are permitted.
- •Has had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
研究组 & 干预措施
TTAC-0001
Experimental
TTAC-0001 with dose assigned to each dose group will be administered
干预措施: TTAC-0001 (Drug)
结局指标
主要结局
Adverse Events
时间窗: until time of progressive disease or 1 year
The frequency and percentage of AEs will be presented by dose goup
次要结局
- Progression free survival rate at 4 months(at the end of 4 months)
- Progression free survival(until time of progressive disease or time point of patients' death which come first assessed up to 1 year)
- Objective response rate(At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days))
- Progression free survival rate at 6 months(at the end of 6 months)
- Overall survival(until time point of patients' death up to 1 year)
- Disease control rate(At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days))
研究者
研究点 (3)
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