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.
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
共同第一作者:
通讯作者:
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
推荐引用方式(GB/T 7714):
Ran Ran,Li Hongtao,Sun Tao,et al.Efficacy and safety of JMT103 in patients with bone metastases from solid tumors: A randomized Phase Ib clinical trial[J].INTERNATIONAL JOURNAL OF CANCER.2025,156(11):2178-2187.doi:10.1002/ijc.35343.
APA:
Ran, Ran,Li, Hongtao,Sun, Tao,Zhou, Huan,Zang, Aimin...&Li, Jin.(2025).Efficacy and safety of JMT103 in patients with bone metastases from solid tumors: A randomized Phase Ib clinical trial.INTERNATIONAL JOURNAL OF CANCER,156,(11)
MLA:
Ran, Ran,et al."Efficacy and safety of JMT103 in patients with bone metastases from solid tumors: A randomized Phase Ib clinical trial".INTERNATIONAL JOURNAL OF CANCER 156..11(2025):2178-2187