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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.
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
Time frame: 10 Days after First Dose of JMT103
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.
Time frame: 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.
Time frame: through study completion, an average of 57 Days
Time to Response
Time to Response
Time frame: through study completion, an average of 57 Days
Time to Complete Response
Time to Complete Response
Time frame: through study completion, an average of 57 Days
Duration of Response
Duration of Response
Time frame: through study completion, an average of 57 Days
Change in Corrected Serum Calcium (CSC)
Change in Corrected Serum Calcium (CSC)
Time frame: through study completion, an average of 57 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in urine N-telopeptide/urine creatinine (uNTx/uCr)
Change in urine N-telopeptide/urine creatinine (uNTx/uCr)
Time frame: through study completion, an average of 57 Days