NCT04198480Unknown1 期
A Phase I/II, Single Arm, Open Label, Multi-center Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory Hypercalcemia of Malignancy
Shanghai JMT-Bio Inc.0 个研究点目标入组 17 人开始时间: 2020年1月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 17
- 主要终点
- Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103
研究概览
简要总结
The purpose of this study is to determine the potential of JMT103 to treat hypercalcemia of malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates.
详细描述
This is a Phase I/II, Single arm, Open Label, Multi-center Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With refractory Hypercalcemia of Malignancy.
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
- •Fully informed and signed informed consent.
- •Male or female, Adults (>/=18 years).
- •Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (CSC) > 12.5 mg/dL (3.1 mmol /L).
- •Last IV bisphosphonate treatment must be >/= 7 days and </= 30 days before the screening corrected serum calcium; or Last hydration therapy must be >/= 24 hours before the screening corrected serum calcium（Incompatible bisphosphonate）.
- •Adequate organ function.
排除标准
- •Hyperparathyroidism, or other granulomatous disease.
- •Hepatitis b surface antigen positive.
- •Hepatitis c antibody positive, or HIV antibody positive.
- •Receiving dialysis for renal failure.
- •Known sensitivity to JMT103 composition.
- •Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of screening CSC.
- •Treatment with cinacalcet within 4 weeks prior to the date of screening CSC.
- •Currently participating another clinical study，or Four weeks or less since receiving an investigational product in another clinical study.
- •In the opinion of the investigator , being unsuitable for inclusion in the study，or subjects withdraw informed consent.
- •Treatment with monoclonal antibody to RANK ligand (RANKL) within 180 days prior to the date of the screening CSC.
研究组 & 干预措施
JMT103
Experimental
Eligible subjects will receive JMT103 at a dose of 2 mg/kg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 2 mg/kg SC on study days 8 and 15.
干预措施: JMT103 (Drug)
结局指标
主要结局
Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103
时间窗: 10 Days after First Dose of JMT103
Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103
次要结局
- Time to Complete Response(through study completion, an average of 57 Days)
- Duration of Response(through study completion, an average of 57 Days)
- Change in Corrected Serum Calcium (CSC)(through study completion, an average of 57 Days)
- Change in urine N-telopeptide/urine creatinine (uNTx/uCr)(through study completion, an average of 57 Days)
- Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL（2.9 mmol/L） by each visit.(through study completion, an average of 57 Days)
- Percentage of Participants With corrected serum calcium (CSC) ≤ 10.8 mg/dL（2.7 mmol/L） by each visit.(through study completion, an average of 57 Days)
- Time to Response(through study completion, an average of 57 Days)
研究者
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