A Phase Ib/II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of JMT103 in Surgically Unsalvageable or Refractory Giant Cell Tumor of Bone
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Percentage of Participants with Giant Cell Tumor Response
研究概览
简要总结
This is a phase Ib/II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of JMT103 in patients with surgically unsalvageable or refractory giant cell tumor of bone (GCTB).
详细描述
The objective of the trial is to evaluate the efficacy and safety of JMT103 in patients with GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.
This study consists of two parts (phase Ib and II). In the phase Ib part, 6 to 12 subjects will be enrolled, and the safety, pharmacokinetics and pharmacodynamics of JMT103 will be evaluated after treatment for more than 4 weeks. And then the phase II part will be conducted, in which, 125 subjects will be enrolled.
Eligible subjects will receive JMT103 at a dose of 2mg/kg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 2mg/kg SC on study days 8 and 15 until disease progression, tumor resection (the pathologic outcome after surgical resection is CR or PR), intolerable toxicity, decision by the participant to discontinue, or decision by the investigator that the subject could no longer benefit from the treatment (whichever occurs first).
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 and older
- •Histologically confirmed GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
排除标准
- •Fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose;
- •Active dental or jaw condition which requires oral surgery, including tooth extraction;
- •Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.);
- •Concurrent treatment with bisphosphonates;
- •Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.
结局指标
主要结局
Percentage of Participants with Giant Cell Tumor Response
时间窗: From enrollment until 12 weeks
A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: at least 90% elimination of giant cells relative to Baseline. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion (PR or CR) at week 12 by radiographic measurements compared with Baseline.
次要结局
- Percentage of Patients with Surgical Resection of Tumor(From enrollment until the last dose, no more than 24 months)
- Time to Progress (TTP)(From enrollment until the last dose, no more than 24 months)
- Proportion of Participants with Adverse Events (AEs)(From enrollment until 90 days after the last dose)
- Number of Participants with Anti-JMT103 Antibodies(From enrollment until 90 days after the last dose)
- Objective Response Rate (ORR)(From enrollment until the last dose, no more than 24 months)
- Serum JMT103 Trough Concentrations(From enrollment until 90 days after the last dose)
- Percent Change from Baseline in Serum C-terminus Peptide (of Type 1 Collagen) and Urinary N-telopeptide Corrected for Urine Creatinine(From enrollment until the last dose, no more than 24 months)
- Changes in Brief Pain Inventory Short Form (BPI-SF)(From enrollment until the last dose, no more than 24 months)
- Disease Control Rate (DCR)(From enrollment until the last dose, no more than 24 months)