A Multi-center, Randomized, Double-blind, Active-controlled, Phase Ⅲ Study to Evaluate Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Giant Cell Objective Tumor Response
研究概览
简要总结
This is a phase Ⅲ, multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of narlumosbart (JMT103) in patients with unresectable or surgically difficult giant cell tumor of bone (GCTB). This clinical trial study hypothesizes narlumosbart administration groups are not inferior to active control administration groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, 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 aged ≥ 18 years or skeletally mature adolescents must weigh at least 45 kg and ≥ 12 years of age;
- •Pathologically confirmed giant cell tumor of bone that is surgically unresectable or for which the planned surgery is associated with functional compromise or morbidity;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
排除标准
- •Previous or ongoing osteomyelitis or osteonecrosis of the jaw, non-healed dental/oral surgery, active dental or jaw condition requiring oral surgery, planned invasive dental procedure during the study;
- •Known or suspected diagnosis of other giant cell-rich tumors, brown cell tumor of bone, or Paget's disease;
- •Known diagnosis of malignancy within the past 5 years, except for definitively treated superficial basal cell carcinoma or cervical carcinoma in situ;
- •Bone metabolic disease including hypo-/hyperparathyroidism, hypo-/hyperthyroidism (except for no need treatment subclinical hypothyroidism), hypopituitarism, hyperprolactinemia, Cushing's syndrome, acromegaly, etc.;
- •Active infections requiring systematic treatment within 7 days prior to randomization;
- •Known human immunodeficiency virus (HIV), syphilis infections or viral hepatitis;
- •Current receiving other anti-tumor therapy (such as radiation, chemotherapy, or embolization, etc.);
- •Concurrent bisphosphonate treatment;
- •Use of anti-receptor activator of nuclear factor-κB ligand (RANKL) antibody within six months prior to screening, or no response to previous RANKL antibody treatment;
- •Known allergic/hypersensitive reaction to JMT103, positive control drug, calcium and vitamin D;
- •Pregnant or lactating females; For those of child bearing potential, refusal to use effective contraception methods from signing informed consent to 6 months after last administration.
研究组 & 干预措施
Narlumosbart
Patients will receive narlumosbart 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15 of the first cycle until one of the following occurred: complete tumor resection, disease progression, intolerable toxicity, decision by the patient to discontinue, or decision by the investigator that the patient could no longer benefit from the treatment.
干预措施: Narlumosbart (Drug)
Denosumab
Patients will receive denosumab 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15 of the first cycle until one of the following occurred: complete tumor resection, disease progression without clinical benefit, decision by the patient to discontinue, or decision by the investigator that the patient could no longer benefit from the treatment.
干预措施: Denosumab (Drug)
结局指标
主要结局
Percentage of Patients With Giant Cell Objective Tumor Response
时间窗: From enrollment until 12 weeks
次要结局
- Time to First Tumor Surgery(From enrollment until the first tumor surgery, up to approximately 4 years)
- Percentage of Patients With Giant Cell Objective Tumor Response(Throughout the study period, up to approximately 4 years)
- Disease Control Rate (DCR)(Up to approximately 4 years)
- Time to Response (TTR)(Up to approximately 4 years)
- Duration of Response (DOR)(Up to approximately 4 years)
- Changes in Brief Pain Inventory Short Form (BPI-SF) score(From enrollment until the last dose, up to approximately 4 years)
- Time to Progression (TTP)(Up to approximately 4 years)
- Percentage of Patients Downstaging the Planned Surgical Procedure(From enrollment until surgery, up to approximately 4 years)
- Types and Proportion of Key Adverse Reactions(From the first dose of study drug until 90 days after the last dose, up to approximately 4 years)
- Serum JMT103 Concentrations(Days 8 of Cycle 1, Day 1 of Cycle 2, 3, 4, 5, 6, and 90 days after the last dose (each cycle is 28 days))
- Number of Patients with Anti-JMT103 Antibodies(Day 1 of Cycle 1, 2, 4, 6, and 90 days after the last dose (each cycle is 28 days))