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| Name | Class |
|---|---|
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | INDUSTRY |
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The purpose of this study is to determine the potential of JMT103 to treat hypercalcemia of malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates.
This is a Phase I/II, Single arm, Open Label, Multi-center Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With refractory Hypercalcemia of Malignancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMT103 | Experimental | Eligible subjects will receive JMT103 at a dose of 2 mg/kg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 2 mg/kg SC on study days 8 and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMT103 | Drug | 2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103 | Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103 | 10 Days after First Dose of JMT103 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL(2.9 mmol/L) by each visit. | Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL(2.9 mmol/L) by each visit. | through study completion, an average of 57 Days |
| Percentage of Participants With corrected serum calcium (CSC) ≤ 10.8 mg/dL(2.7 mmol/L) by each visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XIUGAO YANG | Contact | +86-13811660565 | yangxiugao@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin LI, PHD | Shanghai East Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C562390 | Humoral Hypercalcemia Of Malignancy |
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Percentage of Participants With corrected serum calcium (CSC) ≤ 10.8 mg/dL(2.7 mmol/L) by each visit. |
| through study completion, an average of 57 Days |
| Time to Response | Time to Response | through study completion, an average of 57 Days |
| Time to Complete Response | Time to Complete Response | through study completion, an average of 57 Days |
| Duration of Response | Duration of Response | through study completion, an average of 57 Days |
| Change in Corrected Serum Calcium (CSC) | Change in Corrected Serum Calcium (CSC) | through study completion, an average of 57 Days |
| Change in urine N-telopeptide/urine creatinine (uNTx/uCr) | Change in urine N-telopeptide/urine creatinine (uNTx/uCr) | through study completion, an average of 57 Days |