Safety Assessment of Repeated Administration of a Fully Human Monoclonal Antibody of RNAKL (TK006) in Patients With Breast Cancer-related Bone Metastases
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- Incidence of adverse events（AEs）which are related to TK006 treatment throughout the study
研究概览
简要总结
This is an open labelled study. It was designed to evaluate the safety of multiple-dosing of TK006 in patients with breast cancer-related bone metastases. This trial is the extension of a core study: Phase 1 Trial of a Fully Human Monoclonal Antibody of Receptor Activator for Nuclear Factor-κ B Ligand (RNAKL, TK006) Safety, Pharmacokinetics, and Pharmacodynamics in Patients With Breast Cancer-related Bone Metastases (NCT 03239756).
详细描述
This trial is the extension of a core study: Phase 1 Trial of a Fully Human Monoclonal Antibody of Receptor Activator for Nuclear Factor-κ B Ligand (RNAKL, TK006) Safety, Pharmacokinetics, and Pharmacodynamics in Patients With Breast Cancer-related Bone Metastases (NCT 03239756). It's an open labelled study, aimed at evaluating the safety of repeated administration of TK006 in patients with breast cancer-related bone metastases. The qualified subjects would be those completed the entire observation in either 60 mg, 120 mg or 180 mg single dose arm at the core study. Also, these patients should be well-tolerated with TK006 at the core study and are deemed to further benefit from this extension phase estimated by the researcher and sponsor. The subjects would receive 120 mg TK006 every 4-week over a period of 84 days.
Only safety profile and immunogenicity assessment would be assessed in this extension stage, and no further study on pharmacokinetics and pharmacodynamics would be done.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients provide written informed consent voluntarily.
- •18~65 years old, male or female.
- •Patients who completed the entire observation in either 60 mg, 120 mg or 180 mg single dose arm at the core phase (NCT 03239756). Also, these patients should be well-tolerated with TK006 and would further benefit from continued treatment estimated by the researcher and sponsor.
- •Albumin-adjusted calcium≥2.0mmol/L, ≤2.9mmol/ L.
排除标准
- •Women in pregnancy or nursing.
- •Central nervous system metastasis that is symptomatic or require treatment.
- •Patients with grade III or IV adverse events considered related to TK006 at the core phase (NCT 03239756).
- •Patients with important organs dysfunction and not suitable for further treatment with TK006 judged by the researcher.
- •Imaging confirmed progression in bone metastasis compared with core phase (NCT 03239756).
- •Previous or existing osteomyelitis or osteonecrosis of jaw, toothache or jaw diseases which are in active or require invasive operations, unhealed wound of oral surgery, or planned invasive dental operations during this trial.
- •Patients who have been selected for the study of other test devices or test medicine.
- •Other situations which are not suitable for participation judged by the researcher.
研究组 & 干预措施
treatment group
The subjects would receive 120 mg TK006 every 4-week over a period of 84 days.
干预措施: TK006 (Biological)
结局指标
主要结局
Incidence of adverse events（AEs）which are related to TK006 treatment throughout the study
时间窗: 85 days
Adverse events refer to any treatment related abnormality with clinical significance identified by means of vital signs examination, physical check-up, twelve leads electrocardiogram inspection and laboratory tests throughout the study. Adverse events reported by subjects would also be recorded in the entire trial. All these abnormal cases described above would be reported as incidence of adverse events.
次要结局
- immunogenicity(85 days)