Shanghai East Hospital
Shanghai, 200123, China
NCT Number: NCT04198480
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Shanghai, 200123, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.
Time frame: 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: 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.
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.
Time frame: through study completion, an average of 57 Days
Time to Response
Time frame: through study completion, an average of 57 Days
Time to Complete Response
Time frame: through study completion, an average of 57 Days
Duration of Response
Time frame: through study completion, an average of 57 Days
Change in Corrected Serum Calcium (CSC)
Time frame: through study completion, an average of 57 Days
Change in urine N-telopeptide/urine creatinine (uNTx/uCr)
Shanghai JMT-Bio Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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