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Efficacy and safety of JMT103 in patients with bone metastases from solid tumors: A randomized Phase Ib clinical trial

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机构: [1]Peking Univ Canc Hosp & Inst, Dept Breast Oncol, Key Lab Carcinogenesis & Translat Res, Minist Educ, Beijing, Peoples R China [2]Bengbu Med Univ, Affiliated Hosp 1, Dept Surg Oncol, Bengbu, Peoples R China [3]Dalian Univ Technol, Liaoning Canc Hosp & Inst, Canc Hosp, Shenyang, Peoples R China [4]Hebei Univ, Affiliated Hosp, Dept Med Oncol, Baoding, Peoples R China [5]Nanjing Univ, Nanjing Drum Tower Hosp, Affiliated Hosp, Dept Urol,Med Sch, Nanjing, Peoples R China [6]Nanjing Univ, Inst Urol, Nanjing, Peoples R China [7]Wannan Med Coll, Xuancheng Peoples Hosp, Affiliated Xuancheng Hosp, Dept Oncol, Xuancheng, Peoples R China [8]Peking Univ First Hosp, Dept Med Oncol, Beijing, Peoples R China [9]Beijing Shijitan Hosp, Dept Urol, Beijing, Peoples R China [10]Handan First Hosp, Dept Oncol, Handan, Peoples R China [11]Huizhou Municipal Cent Hosp, Dept Med Oncol, Huizhou, Peoples R China [12]CSPC ZhongQi Pharmaceut Technol Shijiazhuang Co Lt, Shijiazhuang, Peoples R China [13]Tongji Univ, Shanghai East Hosp, Dept Med Oncol, Shanghai, Peoples R China
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关键词: bone metastases JMT103 RANK ligand

摘要:
This study aimed to assess the efficacy and safety of three dosing regimens of JMT103 in patients with bone metastases from solid tumors. Eligible patients were randomly assigned to receive JMT103 subcutaneously, 120 mg every 4 weeks (Cohort 1), 120 mg every 8 weeks (Cohort 2), or 180 mg every 8 weeks (Cohort 3) for up to 49 weeks. The primary endpoint was change from baseline to Week 13 in creatinine-adjusted urinary N-telopeptide (uNTx/Cr). Two hundred and ninety-five patients were randomized, and 293 received at least one dose of JMT103, of whom 96 were assigned to Cohort 1, 97 were assigned to Cohort 2, and 100 were assigned to Cohort 3. The median (interquartile range) percentage reduction in uNTx/Cr at Week 13 was 80.0% (49.9%, 93.4%) in Cohort 1, 73.0% (34.5%, 94.0%) in Cohort 2, and 75.7% (40.4%, 92.0%) in Cohort 3, respectively. On-study skeletal-related events were reported by 3.1% of patients in Cohort 1, 6.2% in Cohort 2, and 7.0% in Cohort 3. Treatment-emergent adverse events occurred in 289 patients, 162 of whom were deemed treatment-related. The most common treatment-related adverse events were hypocalcemia (23.2%), hypophosphatemia (22.9%), and increased aspartate transaminase (11.9%). JMT103 demonstrated a good safety and a strong suppression of the bone turnover markers.

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大类 | 2 区 医学
小类 | 2 区 肿瘤学
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Q1 ONCOLOGY

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第一作者机构: [1]Peking Univ Canc Hosp & Inst, Dept Breast Oncol, Key Lab Carcinogenesis & Translat Res, Minist Educ, Beijing, Peoples R China
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通讯机构: [1]Peking Univ Canc Hosp & Inst, Dept Breast Oncol, Key Lab Carcinogenesis & Translat Res, Minist Educ, Beijing, Peoples R China [13]Tongji Univ, Shanghai East Hosp, Dept Med Oncol, Shanghai, Peoples R China [*1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital and Institute, Beijing, China. [*2]Department of Medical Oncology, Shanghai East Hospital of Tongji University, Shanghai, China
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