Overview
A Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory HCM
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2021-12-31
2021-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shanghai JMT-Bio Inc.Collaborator:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Criteria
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 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.