This is a randomized, open-label, dose-finding, multi-centre, phase Ⅰb study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors.
The objective of this trial is to evaluate the efficacy and safety of JMT103 in patients with bone metastases from solid tumors. Eligible patients will be randomly assigned to receive JMT103 120mg subcutaneously (SC) every 4 weeks (Q4W), 120mg subcutaneously (SC) every 8 weeks (Q8W) and 180mg subcutaneously (SC) every 8 weeks (Q8W) in a 1:1:1 ratio. Patients will receive the treatment until the completion of 48 weeks of treatment, intolerable toxicity, loss to follow-up, withdrawal (patient's decision or investigator's decision), whichever comes first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
295
JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 4-week cycle.
JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 8-week cycle.
JMT103 is administered subcutaneously at a dose of 180 mg on day 1 of each 8-week cycle.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Percentage change of urinary N-terminal telopeptide of type 1 collagen/creatine (U-NTX/Cr) from baseline to week 13
Time frame: From enrollment to week 13.
Incidence and type of adverse events (AEs)
Time frame: From enrollment to 90 days after the last dose
Incidence of Skeletal-related event(SRE)
SRE is defined as pathological fracture, radiotherapy to bone, surgery to bone, or spinal cord compression.
Time frame: From enrollment to 90 days after the last dose
Change in Pain Score (Brief Pain Inventory-Short Form,BPI-SF)
Time frame: From enrollment to 90 days after the last dose
Trough plasma concentration (Ctrough)
Time frame: From enrollment to 90 days after the last dose
Percentage change in serum C-terminus peptide (of Type 1 Collagen) from baseline
Time frame: From enrollment to 90 days after the last dose
Percentage change in serum bone-specific alkaline phosphatase (bALP) from baseline
Time frame: From enrollment to 90 days after the last dose
Number of patients with anti-JMT103 antibodies
Time frame: From enrollment to 90 days after the last dose
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Calcium is given orally at a dose of 500 mg at least, once daily. Vitamin D is given orally at a dose of 400 IU at least, once daily.