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

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

NCT04198480•Shanghai JMT-Bio Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Key Dates

Start Date

January 24, 2020

Primary Completion Date

July 30, 2021

Completion Date

December 31, 2021

Last Updated

December 13, 2019

Enrollment

ESTIMATED participants

Conditions

Hypercalcemia of Malignancy

Interventions

JMT103

DRUG

Contacts

XIUGAO YANG

CONTACT

+86-13811660565 yangxiugao@mail.ecspc.com