A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid

Inclusion criteria

• 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.

Exclusion criteria

• 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.).