Clinical trial · Interventional
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
NCT04198480CI-TRIAL-00042250terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Why stopped (as posted): Due to a change in the company's research strategy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypercalcemia of Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JMT103 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JMT103
- description
- 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.
- interventionNames
- Drug: JMT103
Primary outcomes (1)
- measure
- 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
- description
- Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL Within 10 Days after First Dose of JMT103
Secondary outcomes (7)
- measure
- Percentage of Participants With corrected serum calcium (CSC) ≤ 11.5 mg/dL(2.9 mmol/L) by each visit.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.