Clinical trial NCT04198480: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hypercalcemia of Malignancy
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
Collaborators: name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
First posted: 2019-12-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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 \</= 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.

Primary outcomes:
measure: Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103
timeFrame: 10 Days after First Dose of JMT103
Secondary outcomes:
measure: Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL（2.9 mmol/L） by each visit.
timeFrame: through study completion, an average of 57 Days
measure: Percentage of Participants With corrected serum calcium (CSC) ≤ 10.8 mg/dL（2.7 mmol/L） by each visit.
timeFrame: through study completion, an average of 57 Days
measure: Time to Response
timeFrame: through study completion, an average of 57 Days
measure: Time to Complete Response
timeFrame: through study completion, an average of 57 Days
measure: Duration of Response
timeFrame: through study completion, an average of 57 Days
measure: Change in Corrected Serum Calcium (CSC)
timeFrame: through study completion, an average of 57 Days
measure: Change in urine N-telopeptide/urine creatinine (uNTx/uCr)
timeFrame: through study completion, an average of 57 Days
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai East Hospital
name: Jin LI, PHD
role: PRINCIPAL_INVESTIGATOR
References: