ACTRN12615001156572
已完成
2 期
A Multicenter, 3-Arm, Open-Label, Phase 2a Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients with Recurrent Glioblastoma
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- PharmAbcine Inc.
- 入组人数
- 12
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Both male and female patients at least 19 years old
- •2\. 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.
- •3\. At least one confirmed measurable lesion or non measurable lesion by response assessment in neuro\-oncology (RANO) criteria
- •4\. Karnofsky Performance Status (KPS) at least 80
- •5\. A person who satisfies the following criteria in hematologic, renal, and hepatic function tests
- •a. Hematologic tests
- •Absolute neutrophil count (ANC) at least 1\.5 x 109/L
- •Platelets at least 75 x 109/L
- •Hemoglobin at least 9\.0 g/dL
- •b. Blood coagulation tests
排除标准
- •1\. Diagnosed with malignant tumors, except basal cell carcinoma, cutaneous squamous cell carcinoma, and noninvasive uterine cervical cancer treated within 2 years prior to participating in the study.
- •2\. The following concomitant diseases:
- •a. Uncontrolled hypertension (systolic blood pressure \[SBP] greater than 150 or diastolic blood pressure \[DBP] greater than 90 mmHg)
- •b. Uncontrolled seizures
- •c. Class III or IV heart failure by New York Heart Association (NYHA) classification
- •d. Oxygen\-dependent chronic disease
- •e. Active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder etc.). Treated depression with ongoing antidepressant medication is not an exclusion.
- •3\. Not recovered below National Cancer Institute –Common Terminology for Adverse Events (NCI\-CTCAE) grade 2 from AEs due to CCRT
- •4\. Treatment with systemic chemotherapy, hormonal therapy, immunotherapy or biologic therapy except CCRT or temozolomide alone within 2 weeks prior to the baseline visit
- •5\. 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)
结局指标
主要结局
未指定
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