Hypercalcemia of Malignancy
Conditions
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.
Interventions
DRUGJMT103
2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Shanghai JMT-Bio Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Fully informed and signed informed consent. 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
1. Pregnancy. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | through study completion, an average of 57 Days | Duration of Response |
| Time to Complete Response | through study completion, an average of 57 Days | Time to Complete Response |
| 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) ≤ 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. | 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. |
| Time to Response | through study completion, an average of 57 Days | Time to Response |
| Change in Corrected Serum Calcium (CSC) | through study completion, an average of 57 Days | Change in Corrected Serum Calcium (CSC) |
| Change in urine N-telopeptide/urine creatinine (uNTx/uCr) | through study completion, an average of 57 Days | Change in urine N-telopeptide/urine creatinine (uNTx/uCr) |
Contacts
Primary ContactXIUGAO YANG
Outcome results
None listed