A Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory HCM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hypercalcemia of Malignancy

Intervention / Treatment
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* Drug: JMT103


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fully informed and signed informed consent. Male or female, Adults (>/=18 years). Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (CSC) > 12.5 mg/dL (3.1 mmol /L). Last IV bisphosphonate treatment must be >/= 7 days and </= 30 days before the screening corrected serum calcium; or Last hydration therapy must be >/= 24 hours before the screening corrected serum calcium（Incompatible bisphosphonate）. Adequate organ function. Exclusion Criteria: Pregnancy. Hyperparathyroidism, or other granulomatous disease. Hepatitis b surface antigen positive. Hepatitis c antibody positive, or HIV antibody positive. Receiving dialysis for renal failure. Known sensitivity to JMT103 composition. Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of screening CSC. Treatment with cinacalcet within 4 weeks prior to the date of screening CSC. Currently participating another clinical study，or Four weeks or less since receiving an investigational product in another clinical study. In the opinion of the investigator , being unsuitable for inclusion in the study，or subjects withdraw informed consent. Treatment with monoclonal antibody to RANK ligand (RANKL) within 180 days prior to the date of the screening CSC.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JMT103<br>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. | Drug: JMT103<br>* 2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |