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Terminated

NCT Number: NCT04198480

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

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.

Why the study stopped: Due to a change in the company's research strategy
Terminated

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai East Hospital

Shanghai, 200123, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fully informed and signed informed consent.
  • Male or female, Adults (>/=18 years).
  • 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).
  • 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).
  • Adequate organ function.

Exclusion criteria

  • Pregnancy.
  • Hyperparathyroidism, or other granulomatous disease.
  • Hepatitis b surface antigen positive.
  • Hepatitis c antibody positive, or HIV antibody positive.
  • Receiving dialysis for renal failure.
  • Known sensitivity to JMT103 composition.
  • 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.
  • Treatment with cinacalcet within 4 weeks prior to the date of screening CSC.
  • Currently participating another clinical study,or Four weeks or less since receiving an investigational product in another clinical study.
  • In the opinion of the investigator , being unsuitable for inclusion in the study,or subjects withdraw informed consent.
  • Treatment with monoclonal antibody to RANK ligand (RANKL) within 180 days prior to the date of the screening CSC.

Treatment and study plan

JMT103

Drug

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

Primary outcomes

  1. Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103

    Time frame: 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

Secondary outcomes

  1. Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL(2.9 mmol/L) by each visit.

    Time frame: through study completion, an average of 57 Days

    Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL(2.9 mmol/L) by each visit.

  2. Percentage of Participants With corrected serum calcium (CSC) ≤ 10.8 mg/dL(2.7 mmol/L) by each visit.

    Time frame: 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.

  3. Time to Response

    Time frame: through study completion, an average of 57 Days

    Time to Response

  4. Time to Complete Response

    Time frame: through study completion, an average of 57 Days

    Time to Complete Response

  5. Duration of Response

    Time frame: through study completion, an average of 57 Days

    Duration of Response

  6. Change in Corrected Serum Calcium (CSC)

    Time frame: through study completion, an average of 57 Days

    Change in Corrected Serum Calcium (CSC)

  7. Change in urine N-telopeptide/urine creatinine (uNTx/uCr)

    Time frame: through study completion, an average of 57 Days

    Change in urine N-telopeptide/urine creatinine (uNTx/uCr)

Sponsors and collaborators

Lead sponsor

Shanghai JMT-Bio Inc.

Industry

Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2019
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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