Clinical trial · Interventional
A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid
A Phase III, Multicenter, Randomized, Double-blind Clinical Trail to Assess JMT103 Compared to Azoledronic Acid for the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors
NCT06221072CI-TRIAL-00073275not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid.
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 |
|---|---|---|---|
| Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JMT103 | Drug | — | UNRESOLVED |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1-JMT103
- description
- Participants will receive JMT103 and zoledronic acid placebo.
- interventionNames
- Drug: JMT103
- type
- EXPERIMENTAL
- label
- Group 2-zoledronic acid
- description
- Participants will receive zoledronic acid and JMT103 placebo.
- interventionNames
- Drug: zoledronic acid
Primary outcomes (1)
- measure
- Time to the First on-study Skeletal-Related Event (SRE)
- timeFrame
- Up to approximately 48 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: older than 18 years; 2. Breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone \<50 ng/dL or 1.7 nmol/L and serum PSA progression after surgery or drug castration treatment); 3. Patients with imaging studies showing at least one tumor bone metastasis; 4. With a good organ function; 5. Expected survival of at least 6 months. Exclusion Criteria: 1. Previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period; 2. Radiotherapy or surgery for the bone metastases is planned during the study; 3. Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI/CT examination to exclude patients with brain metastasis); 4. Patients with bone metabolic diseases \[e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.\]; 5. Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP\> 150/90 mmHg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction \<50%; 6. Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose; 7. Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.).
References
Publications (0)
Data not yet available
No reference posted for this study.