A Clinical Trial to Assess the Efficacy and Safety of JMT103 in Patients With Refractory HCM

Hypercalcemia of Malignancy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04198480
• Other study ID #: JMT103CN04
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 24, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2019
• Source: Shanghai JMT-Bio Inc.
• Contact: XIUGAO YANG
• Phone: +86-13811660565
• Email: yangxiugao[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17
• Est. completion date: December 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypercalcemia
• Hypercalcemia of Malignancy
• Neoplasms
• Paraneoplastic Syndromes

Intervention

Drug:
• JMT103
2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai JMT-Bio Inc.	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 Days after First Dose of JMT103
Secondary	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.	through study completion, an average of 57 Days
Secondary	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.	through study completion, an average of 57 Days
Secondary	Time to Response	Time to Response	through study completion, an average of 57 Days
Secondary	Time to Complete Response	Time to Complete Response	through study completion, an average of 57 Days
Secondary	Duration of Response	Duration of Response	through study completion, an average of 57 Days
Secondary	Change in Corrected Serum Calcium (CSC)	Change in Corrected Serum Calcium (CSC)	through study completion, an average of 57 Days
Secondary	Change in urine N-telopeptide/urine creatinine (uNTx/uCr)	Change in urine N-telopeptide/urine creatinine (uNTx/uCr)	through study completion, an average of 57 Days