NCT06221072尚未招募3 期
A Phase III, Multicenter, Randomized, Double-blind Clinical Trail to Assess JMT103 Compared to Azoledronic Acid for the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors
Shanghai JMT-Bio Inc.0 个研究点目标入组 1,360 人开始时间: 2024年4月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,360
- 主要终点
- Time to the First on-study Skeletal-Related Event (SRE)
研究概览
简要总结
This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
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
- •Age: older than 18 years;
- •Breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone <50 ng/dL or 1.7 nmol/L and serum PSA progression after surgery or drug castration treatment);
- •Patients with imaging studies showing at least one tumor bone metastasis;
- •With a good organ function;
- •Expected survival of at least 6 months.
排除标准
- •Previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period;
- •Radiotherapy or surgery for the bone metastases is planned during the study;
- •Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI/CT examination to exclude patients with brain metastasis);
- •Patients with bone metabolic diseases [e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.];
- •Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP> 150/90 mmHg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction <50%;
- •Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose;
- •Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.).
研究组 & 干预措施
Group 1-JMT103
Experimental
Participants will receive JMT103 and zoledronic acid placebo.
干预措施: JMT103 (Drug)
Group 2-zoledronic acid
Experimental
Participants will receive zoledronic acid and JMT103 placebo.
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Time to the First on-study Skeletal-Related Event (SRE)
时间窗: Up to approximately 48 months
次要结局
- Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr)(Up to approximately 28 months)
- Quality of life score (concise pain assessment Scale and EQ-5D-5L scale);(Up to approximately 48 months)
- Incidence and severity of adverse events (AEs)(Up to approximately 48 months)
- Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE)(Up to approximately 48 months)
- JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab)(Up to approximately 48 months)
- Serum concentration of JMT103(Up to approximately 48 months)
- Overall survival (OS)(Up to approximately 6 years)
研究者
相似试验
已完成
3 期
Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's DiseaseCushing's DiseaseNCT01374906Novartis Pharmaceuticals150
进行中（未招募）
3 期
Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)Chronic Kidney Disease With High ProteinuriaNCT06087835AstraZeneca1,835
已完成
3 期
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent PatientsGastroesophageal Reflux Disease (GERD)NCT00241501AstraZeneca140
已完成
3 期
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast CancerHER2-positive Breast CancerNCT03588091Jiangsu HengRui Medicine Co., Ltd.355
Unknown
3 期
A Efficacy and Safety Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung CancerAdvanced Non-squamous Cell Non-small Cell Lung CancerNCT04439890Chia Tai Tianqing Pharmaceutical Group Co., Ltd.369