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.
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;
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.];
Parallel
JMT103
Drug120 mg by subcutaneous injection every 4 weeks
zoledronic acid
Drug4 mg by intravenous drip (100mL:4mg) every 4 weeks
Time to the First on-study Skeletal-Related Event (SRE)
Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE)
Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr)
Quality of life score (concise pain assessment Scale and EQ-5D-5L scale);
Incidence and severity of adverse events (AEs)
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This trial is not recruiting at the moment. You can still explore other options:
