A Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory HCM
NCT ID: NCT04198480
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
17 participants
INTERVENTIONAL
2020-01-24
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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JMT103
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.
JMT103
2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.
Interventions
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JMT103
2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.
Eligibility Criteria
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Inclusion Criteria
2. Male or female, Adults (\>/=18 years).
3. 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).
4. 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）.
5. Adequate organ function.
Exclusion Criteria
2. Hyperparathyroidism, or other granulomatous disease.
3. Hepatitis b surface antigen positive.
4. Hepatitis c antibody positive, or HIV antibody positive.
5. Receiving dialysis for renal failure.
6. Known sensitivity to JMT103 composition.
7. 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.
8. Treatment with cinacalcet within 4 weeks prior to the date of screening CSC.
9. Currently participating another clinical study，or Four weeks or less since receiving an investigational product in another clinical study.
10. In the opinion of the investigator , being unsuitable for inclusion in the study，or subjects withdraw informed consent.
11. Treatment with monoclonal antibody to RANK ligand (RANKL) within 180 days prior to the date of the screening CSC.
18 Years
ALL
No
Sponsors
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
INDUSTRY
Shanghai JMT-Bio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jin LI, PHD
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital
Central Contacts
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Other Identifiers
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JMT103CN04
Identifier Type: -
Identifier Source: org_study_id