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This is a phase â…¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-JMT103 | Experimental | Participants will receive JMT103 and zoledronic acid placebo. |
|
| Group 2-zoledronic acid | Experimental | Participants will receive zoledronic acid and JMT103 placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMT103 | Drug | 120 mg by subcutaneous injection every 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First on-study Skeletal-Related Event (SRE) | Up to approximately 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE) | Up to approximately 48 months | |
| Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr) | Up to approximately 28 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn | |
| Zefei Jiang, M.D | Contact | 13901372170 | jzf_cscobc@csco.org.cn |
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multicenter, randomized, double-blind clinical Trail
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Double-blind
| zoledronic acid |
| Drug |
4 mg by intravenous drip (100mL:4mg) every 4 weeks |
|
| Quality of life score (concise pain assessment Scale and EQ-5D-5L scale); | Up to approximately 48 months |
| Incidence and severity of adverse events (AEs) | Up to approximately 48 months |
| JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab) | Up to approximately 48 months |
| Serum concentration of JMT103 | Up to approximately 48 months |
| Overall survival (OS) | Up to approximately 6 years |
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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