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

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.

Study Overview

• Status: Unknown
• Conditions: Hypercalcemia of Malignancy
• Intervention / Treatment: Drug: JMT103

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.

• Study Type: Interventional
• Enrollment (Anticipated): 17
• Phase: Phase 2; Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: JMT103; Eligible subjects will receive JMT103 at a dose of 2 mg/kg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 2 mg/kg SC on study days 8 and 15.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time to Response	Time to Response	through study completion, an average of 57 Days
Time to Complete Response	Time to Complete Response	through study completion, an average of 57 Days
Duration of Response	Duration of Response	through study completion, an average of 57 Days
Change in Corrected Serum Calcium (CSC)	Change in Corrected Serum Calcium (CSC)	through study completion, an average of 57 Days
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

Collaborators and Investigators

• Sponsor: Shanghai JMT-Bio Inc.
• Collaborators: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 24, 2020
• Primary Completion (ANTICIPATED): July 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Neoplasms; Paraneoplastic Syndromes; Hypercalcemia
• Other Study ID Numbers: JMT103CN04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No