UnknownPhase 1/2

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

17 participantsStarted 2020-01-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Trial details

NCT IDNCT04198480

SponsorShanghai JMT-Bio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-30

Contact for this trial

XIUGAO YANG

+86-13811660565 yangxiugao@mail.ecspc.com

View on ClinicalTrials.gov More Hypercalcemia of Malignancy trials