Back to resultsA Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory HCM
Primary Purpose
Hypercalcemia of Malignancy
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
JMT103
Sponsored by
About this trial
This is an interventional treatment trial for Hypercalcemia of Malignancy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JMT103
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Time to Response
Time to Response
Time to Complete Response
Time to Complete Response
Duration of Response
Duration of Response
Change in Corrected Serum Calcium (CSC)
Change in Corrected Serum Calcium (CSC)
Change in urine N-telopeptide/urine creatinine (uNTx/uCr)
Change in urine N-telopeptide/urine creatinine (uNTx/uCr)
Full Information
NCT ID
NCT04198480
First Posted
November 27, 2019
Last Updated
December 11, 2019
Sponsor
Shanghai JMT-Bio Inc.
Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04198480
Brief Title
A Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory HCM
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 24, 2020 (Anticipated)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai JMT-Bio Inc.
Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercalcemia of Malignancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JMT103
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JMT103
Intervention Description
2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.
Primary Outcome Measure Information:
Title
Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103
Description
Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103
Time Frame
10 Days after First Dose of JMT103
Secondary Outcome Measure Information:
Title
Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL（2.9 mmol/L） by each visit.
Description
Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL（2.9 mmol/L） by each visit.
Time Frame
through study completion, an average of 57 Days
Title
Percentage of Participants With corrected serum calcium (CSC) ≤ 10.8 mg/dL（2.7 mmol/L） by each visit.
Description
Percentage of Participants With corrected serum calcium (CSC) ≤ 10.8 mg/dL（2.7 mmol/L） by each visit.
Time Frame
through study completion, an average of 57 Days
Title
Time to Response
Description
Time to Response
Time Frame
through study completion, an average of 57 Days
Title
Time to Complete Response
Description
Time to Complete Response
Time Frame
through study completion, an average of 57 Days
Title
Duration of Response
Description
Duration of Response
Time Frame
through study completion, an average of 57 Days
Title
Change in Corrected Serum Calcium (CSC)
Description
Change in Corrected Serum Calcium (CSC)
Time Frame
through study completion, an average of 57 Days
Title
Change in urine N-telopeptide/urine creatinine (uNTx/uCr)
Description
Change in urine N-telopeptide/urine creatinine (uNTx/uCr)
Time Frame
through study completion, an average of 57 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XIUGAO YANG
Phone
+86-13811660565
Email
yangxiugao@mail.ecspc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin LI, PHD
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory HCM
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